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Are interested to manufacture Hemostatic product? product similar to Surgifom, Gelafoam, Abgel, cutanplast, spongostan.

 

we can help you Complete Manufacturing set up of Absorbable Gelatin Sponge Project and ISO 13485 and CE certification.

We at INSTASPON provide hemostatic product manufacturing consultancy services, ISO 13485:2016 and ISO 9001:2015 documentation services for Absorbable gelatin sponge Hemostatic Medical Devices (eg. Absorbable Gelatin Sponge). we are provide support in CE certification as per new EU-MDR.

 

By associating yourself and your products developed by collaborating with us, you would be benefited with our already established contacts all over the World / especially europe, with world class end-to-end services provided at a highly competitive price.

Also, our strength is to pursue below mentioned services.

    • Support of Indian Notified body and certification body  ISO 13485:2016 and CE as per EU-MDR.

    • Grant of License for Manufacturing and sales of Class C and Class D as per CDSCO MDR 2017 Rule.

    • Medical devices (India) Device master file preparation and maintenance · Plant master file preparation and maintenance and Technical files preparation for CE marking ·

    • Biocompatibility testing of Medical devices. gamma irradiation supports 

    • Clean room process sourcing Please share your requirement with us,

 

 



INSTASPON hemostatic gelatin sponge. Most trusted gelatin sponge brand with the highest quality standard

 

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         ABOUT INSTASPON GELATIN SPONGE 

            > INSTASPON –  gelatin sponge designed to rapid hemostasis and ready to use dry.

            > After 5 Years of continuous research INSTASPON Gelatin sponge developed for rapid hemostasis

            > Sterile Gelatin Sponge is a Medical device intended for application to bleeding surfaces to achieve hemostasis

            > Gelatin sponge cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids.

            > Gelatin sponge is a water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified Gelatin.

 

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           INSTASPON GELATIN SPONGE FEATURES

               > Non-toxic, non-allergenic, non-immunologic and non-pyrogenic

               > Gamma sterilized – sterility confirms.

               > Biocompatibility passed according to ISO 10993 absorb in the body within 4 – 6 weeks when placed in tissues

               > Absorbs 40-50 times of blood in relation to its weight

               > It is produced of highly purified gelatin

               > READY to applied dry and soaked with antibiotics or with thrombin sealant

               > Has a neutral pH

               > Easy to use, Best quality, Safe, Reliable

               > Stop all kinds of oozing blood (capillary, parenchymal, or arteriovenous)

               > Complies with US Pharmacopoeia standards

               > Available in many sizes to fit common surgical procedures

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            ACTIONS of INSTASPON Gelatin Sponge

                > INSTASPON gelatin Sponge has hemostatic properties.

                > INSTASPON gelatin Sponge absorbs completely, with little tissue reaction, when excessive amounts are not used.

                 > When used in appropriate amounts, INSTASPON gelatin Sponge is absorbed completely within 4 to 6 weeks.

                 > In an animal implantation study, tissue reactions were  negligible when observed  macroscopically, and moderate when observed        

                 >When applied to bleeding mucosal regions, it liquefies within 2 to 5 days.

 

           

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           How to use INSTASPON- Absorbable Gelatin sponge

              A) Dry Use:

              1. Cut the INSTASPON Gelatin Sponge to the desired size and shape.

              2. Manually compress the INSTASPON Gelatin Sponge prior to applying to the bleeding site.

              3. Hold the INSTASPON Gelatin Sponge in place with moderate pressure until hemostasis is achieved.

              4. Removal of excess INSTASPON Gelatin Sponge upon achieving

              5. hemostasis can be accomplished by gentle irrigation of the site with a sterile saline solution to completely wet the sponge.

             6.Use only the amount required to achieve hemostasis and remove any excess.

   

             B) Use With Sterile Saline or Thrombin Preparation:

            1. Cut the INSTASPON Gelatin Sponge to the desired size and shape

            2. Immerse the INSTASPON Gelatin Sponge cut to size in the solution.

            3. Withdraw sponge and squeeze between gloved fingers to expel air bubbles.

            4. Return sponge to the solution until needed. 

            5. Blot sponge to desired dampness on gauze before applying to the bleeding site.

            6. Hold the INSTASPON Gelatin Sponge in place with gauze using moderate pressure until hemostasis is achieved.

           7. Removal of gauze is aided by wetting with a few drops of saline, which helps prevent removal of the INSTASPON Gelatin Sponge and clot.

 

 

       

 

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INSTASPON GELATIN SPONGE SPECIFICATION COMPLIES USP

TEST

SPECIFICATION

Solubility in water

Insoluble in water

Water absorbability

Absorb 45-50 times of its weight

Digestibility

Not more then 40 minutes

Residue on ignition

Not more then 2.0%

Sterility

 Sterile – gamma sterilize as per ISO 11137

 

     

         INSTASPON GELATIN SPONGE MECHANISM OF ACTION: 

           > INSTASPON GELATIN SPONGE Mode of action is by formation of mechanical matrix that facilitates clotting.

           > It adheres to bleeding site and absorbs around 40-50 times of its own weight of blood.

           > Porous structure activates thrombocytes which triggers the release of substances that facilitates self-aggregation.

           > At the same time, it also makes thrombocytes to act as a catalyst for the formation of the fibrin, activating cascade of blood coagulation.

   

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        where to use INSTASPON – Absorbable Gelatin Sponge?

          > As a Hemostat in surgery,

          > Vascular Surgery, Partial Nephrectomy, Plastic Surgery, Gynaecological Surgery,

          > Orthopaedic Surgery, Otolaryngological Surgery, Otolaryngological Surgery

          > Anorectal Surgery, Abdominal Surgery, Dental Surgery, ENT Surgery, Hysterectomy, Neuro Surgery

 

   INSTASPON AVAILABLE IN DIFFERENT SIZES AS PER INTENDED USE

        we also provide custom size manufacturing as per customer need

        Prices depend upon the size and quantity of the product

 

INSTASPON GELATIN SPONGE  AVAILABLE IN DIFFERENT SIZES

Product code

Product Name

Size (mm)

IS 805010

Instaspon Standard

80 x 50 x 10

IS 705010

Instaspon Standard

70 x 50 x 10

IS 805001

Instaspon Special

80 x 50 x 01

IS 705001

Instaspon Special

70 x 50 x 01

IS 8030

Instaspon anal Tampon

80 x 30

IS 101010

Instaspon Dental

10 x 10 x 10

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FREQUENTLY ASKED QUESTIONS

 

            (1) What is Absorbable gelatin sponge and its Mode of action?

            > INSTASPON Absorbable gelatin sponge best Hemostatic  Medical Device which is manufactured from purified gelatin 

            > intended for Rapid hemostatic action during surgery.

            > INSTASPON GELATIN SPONGE Mode of action is by formation of mechanical matrix that facilitates clotting. it adheres to bleeding site and

            > absorbs around 50 times of its own weight of blood. porous structure activates thrombocytes

            > which triggers the release of substances that facilitates their aggregation

 

          (2) What is the use of Absorbable Gelatin sponge?

          > Absorbable gelatin sponge is useful in most of surgical procedures to achieve homeostasis.

          > gelatin sponge uses in neurosurgery. to combine with topical thrombin it is uses in surgery         

          > gelatin sponge also useful in vaternery surgery  

          > use in general digestive surgery

          > use in ent surgery 

          > use in dental surgery 

          >use in plastic surgery

          > abdominal surgery

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