Identity
- Trade Name
- GELFOAM-JMI™ Sponge Kit FDA UDI
- Generic Name
- General surgical procedure kit, medicated FDA UDI
- Device Name
- Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Sponge USP and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 International Units) FDA UDI
- Model / Reference
- Size 100 FDA UDI
- Description
- Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Sponge USP and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 International Units) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00360793310107 FDA UDI
- FDA Product Code
- LMF FDA UDI
- GMDN Term
- General surgical procedure kit, medicated FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.4490 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
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
Yes
FDA UDI
Category: General surgical procedure kit, medicated
GELFOAM-JMI™ Sponge Kit by Pharmacia & Upjohn Co. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General surgical procedure kit, medicated.
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- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
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Cleared under the same submission
N18286 also covers:
- GEL-FLOW KIT — Pharmacia & Upjohn Co.
- GEL-FLOW™ NT — Pharmacia & Upjohn Co.
- GELFOAM-JMI™ Powder Kit — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
- Gelfoam — Pharmacia & Upjohn Co.
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pharmacia & Upjohn Co.
Sources (1)
- FDA UDI 82696ab3-3151-43b2-b0b1-c2515bd2bb9a 36 fields · synced May 30, 2026