Identity
- Trade Name
- DeScribe Transparent PFD Patch FDA UDI
- Generic Name
- Synthetic polymer semi-permeable film dressing, adhesive, non-sterile FDA UDI
- Device Name
- Individually packaged DeScribe PFD Patch (each) Contains 5 DeScribe PFD Patches. FDA UDI
- Model / Reference
- 5035838 FDA UDI
- Description
- Individually packaged DeScribe PFD Patch (each) Contains 5 DeScribe PFD Patches. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00186295000342 FDA UDI
- FDA Product Code
- PKO FDA UDI
- GMDN Term
- Synthetic polymer semi-permeable film dressing, adhesive, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
No
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: Synthetic polymer semi-permeable film dressing, adhesive, non-sterile
DeScribe Transparent PFD Patch by Merz North America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic polymer semi-permeable film dressing, adhesive, non-sterile.
- View Guard Transparent Film Dressing Roll — Dynarex Corp. · Class I
- 3M™ Tegaderm™ — 3M COMPANY · Class I
- View Guard Transparent Film Dressing Roll — Dynarex Corp. · Class I
- View Guard Transparent Film Dressing Roll — Dynarex Corp. · Class I
- 3M™ Tegaderm™ — 3M COMPANY · Class I
- 3M™ Tegaderm™ — 3M COMPANY · Class I
- DeScribe Transparent PFD Patch — On Light Sciences, Inc. · Class II
- View Guard Transparent Film Dressing Roll — Dynarex Corp. · Class I
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 II | Pending data |
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Manufacturer
- Manufacturer
- Merz North America, Inc.
Sources (1)
- FDA UDI ecda83d8-4c06-431e-a9a2-b7348eeb20c9 34 fields · synced Jun 9, 2026