Identity
- Trade Name
- Oil Emulsion Dressing (3 x 3 in) FDA UDI
- Generic Name
- Petrolatum woven gauze pad FDA UDI
- Model / Reference
- GEN-19000 FDA UDI
Identifiers
- Catalog Number
- GEN-19000 FDA UDI
- Primary DI / UDI-DI
- 00361554003221 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Petrolatum woven gauze pad FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Petrolatum woven gauze pad
Oil Emulsion Dressing (3 x 3 in) by Gentell — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Petrolatum woven gauze pad.
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · U
- PETROLATUM GAUZE® — Derma Sciences Canada, Inc · Class II
- Vitale — CellEra, LLC · Class I
- Polynew — Roosin Medical Co., Ltd. · U
- Simpurity — SAFE N SIMPLE LLC · Class I
- Vitale — CellEra, LLC · Class I
- PETROLATUM GAUZE® — Derma Sciences Canada, Inc · Class II
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · U
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gentell
Sources (1)
- FDA UDI d68d3e24-ac8a-44b0-b8f2-6206f6bae6fc 33 fields · synced May 30, 2026