Identity
- Trade Name
- Vitale FDA UDI
- Generic Name
- Petrolatum woven gauze pad FDA UDI
- Device Name
- Petrolatum Gauze Strips, 3" x 9", 50/box, 8boxes/case FDA UDI
- Model / Reference
- 56309 FDA UDI
- Description
- Petrolatum Gauze Strips, 3" x 9", 50/box, 8boxes/case FDA UDI
Identifiers
- Catalog Number
- 56309 FDA UDI
- Primary DI / UDI-DI
- 00856276008901 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Petrolatum woven gauze pad
Vitale by CellEra, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Petrolatum woven gauze pad.
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- Simpurity — SAFE N SIMPLE LLC · Class I
- PETROLATUM GAUZE® — Derma Sciences Canada, Inc · Class II
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · U
- Dukal — Dukal LLC · U
- Dukal — Dukal LLC · 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 |
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Manufacturer
- Manufacturer
- CellEra, LLC
Sources (1)
- FDA UDI 6cd98c60-1f4e-4760-bba8-17db1087336f 35 fields · synced Jun 1, 2026