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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