Identity
- Trade Name
- GEL-FLOW KIT FDA UDI
- Generic Name
- General surgical procedure kit, medicated FDA UDI
- Device Name
- GEL-FLOW NT Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI, 5,000 International Units Syringe Spray Kit FDA UDI
- Model / Reference
- 6 mL FDA UDI
- Description
- GEL-FLOW NT Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI, 5,000 International Units Syringe Spray Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00300092250018 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
Yes
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
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
Category: General surgical procedure kit, medicated
Gel-Flow Kit by Pharmacia & Upjohn Co. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General surgical procedure kit, medicated.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Cleared under the same submission
N18286 also covers:
- GEL-FLOW™ NT — Pharmacia & Upjohn Co.
- GELFOAM-JMI™ Powder Kit — Pharmacia & Upjohn Co.
- GELFOAM-JMI™ Sponge 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 083964e9-7d44-41de-9b57-ce7d2d9c9835 36 fields · synced Jun 6, 2026