Identity
- Trade Name
- Protect U Guard Hydrocolloid Sterile Dressing FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
- Device Name
- Protect U Guard Hydrocolloid Sterile Dressing Sacral 14x18cm FDA UDI
- Model / Reference
- P19102 FDA UDI
- Description
- Protect U Guard Hydrocolloid Sterile Dressing Sacral 14x18cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B086191021 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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 — 14 Centimeter FDA UDILength — 18 Centimeter FDA UDI
Category: Exudate-absorbent dressing, non-gel, antimicrobial
Protect U Guard Hydrocolloid Sterile Dressing by Protect U Guard, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Exudate-absorbent dressing, non-gel, antimicrobial.
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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 313a69d8-3068-44ea-b937-489c50c223c8 35 fields · synced Jun 1, 2026