OSSEOUS Gelatin Sponge

FDA UDI

Class I (US FDA UDI)

by Eon Meditech Private Limited

Identity

Trade Name: OSSEOUS Gelatin Sponge FDA UDI
Generic Name: Gelatin haemostatic agent FDA UDI
Device Name: "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. " FDA UDI
Model / Reference: E91108050 FDA UDI
Description: "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. " FDA UDI

Identifiers

Primary DI / UDI-DI: 08906039313192 FDA UDI
FDA Product Code: LAY FDA UDI
GMDN Term: Gelatin haemostatic agent FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.3280 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 80 Millimeter FDA UDI
Width — 50 Millimeter FDA UDI
Height — 10 Millimeter FDA UDI

Category: Gelatin haemostatic agent

OSSEOUS Gelatin Sponge by Eon Meditech Private Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gelatin haemostatic agent.

ORCA Foam — ORCA PRODUCTS LLC · Class I
ORCA Foam — ORCA PRODUCTS LLC · Class I
SURGIFLO® Hemostatic Matrix — Ferrosan Medical Devices A/S · Class III
SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. — Ferrosan Medical Devices A/S · Class III
SURGIFOAM® Absorbable Gelatin Powder Kit — Ferrosan Medical Devices A/S · Class III
SURGIFLO® Hemostatic Matrix Kit with Thrombin — Ferrosan Medical Devices A/S · Class III
ORCA Foam — ORCA PRODUCTS LLC · Class I
SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. — Ferrosan Medical Devices A/S · Class III

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Eon Meditech Private Limited

Sources (1)

FDA UDI 0cde8c2e-e239-4a4f-a46d-7c8e401642ec 35 fields · synced Jun 1, 2026