OSSEOUS Gelatin Sponge Sterifen

GUDID 08904428748181

"Absorbable Haemostatic Gelatin Sponge is a sterile malleable, water-insoluble, Gelatin absorbable sponge intended for haemostatic use by applying to a bleeding surface. Absorbable Haemostatic Gelatin Sponge is non-pyrogenic and biocompatible. Absorbable Haemostatic Gelatin Sponge is a surgical haemostatic sponge, manufactured from highly purified first grade gelatin material for use in various surgical procedures. When implanted in vivo and used in appropriate amounts, it is completely absorbed within 3-4 weeks. When applied to bleeding mucosal regions, it liquefies within 2 to 5 days. Absorbable Haemostatic Gelatin Sponge have a porous structure which activates the thrombocytes at the moment blood comes in contact with the matrix of the sponge. This causes the thrombocytes to release a series of substances which promote their aggregation at the same time as their surfaces change character, thus enabling them to act as a catalyst for the formation of the fibrin. "

EON MEDITECH PRIVATE LIMITED

Gelatin haemostatic agent

• Primary Device ID: 08904428748181
• NIH Device Record Key: b35de0c3-9eac-4e7d-be9a-f55002aa9972
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSEOUS Gelatin Sponge Sterifen
• Version Model Number: E91108040
• Company DUNS: 930270428
• Company Name: EON MEDITECH PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter
• Length: 80 Millimeter
• Width: 40 Millimeter
• Height: 10 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08904428748181 [Package]; Contains: 08906039313215; Package: Laminated Box [10 Units]; In Commercial Distribution
GS1	08906039313215 [Primary]

FDA Product Code

• LAY: Methotrexate Control Materials

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-12
• Device Publish Date: 2024-07-04

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