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Gelfoam Plus

FDA UDI

Class III (US FDA UDI)

by Baxter Healthcare Corp

Identity

Trade Name
Gelfoam Plus FDA UDI
Generic Name
Collagen haemostatic agent, non-antimicrobial FDA UDI
Device Name
GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device FDA UDI
Model / Reference
1501341 FDA UDI
Description
GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device FDA UDI

Identifiers

Catalog Number
1501341 FDA UDI
Primary DI / UDI-DI
00085412086309 FDA UDI
FDA Product Code
LMF FDA UDI
GMDN Term
Collagen haemostatic agent, non-antimicrobial FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
878.4490 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Gelfoam Plus by Baxter Healthcare Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baxter Healthcare Corp

Sources (1)

  • FDA UDI 530a8ae7-0cfd-4f4d-a261-22a2056c9094 37 fields · synced May 30, 2026