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Protect U Guard Transparent Sterile Dressing PU Incise
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Protect U Guard Transparent Sterile Dressing PU Incise FDA UDI
- Generic Name
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- Protect U Guard Transparent Sterile Dressing PU Incise 30x40cm FDA UDI
- Model / Reference
- P19154 FDA UDI
- Description
- Protect U Guard Transparent Sterile Dressing PU Incise 30x40cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B086191541 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Synthetic polymer semi-permeable film dressing, adhesive 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 30 Centimeter FDA UDILength — 40 Centimeter FDA UDI
Category: Synthetic polymer semi-permeable film dressing, adhesive
Protect U Guard Transparent Sterile Dressing PU Incise by Protect U Guard, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Synthetic polymer semi-permeable film dressing, adhesive.
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- Suprasorb — Lohmann & Rauscher International GmbH & Co KG · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Protect U Guard, Llc
Sources (1)
- FDA UDI c93edcbf-7187-4e2b-a8da-cbf5ed0ff20e 35 fields · synced Jun 1, 2026