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 10x10cm FDA UDI
- Model / Reference
- P19101 FDA UDI
- Description
- Protect U Guard Hydrocolloid Sterile Dressing 10x10cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B086191011 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 — 10 Centimeter FDA UDILength — 10 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
Similar devices
Also classified as Exudate-absorbent dressing, non-gel, antimicrobial.
- MANUKAhd Lite 10 x 12.5 cm — MANUKAMED LIMITED PARTNERSHIP · U
- Areza Medical — ADVANCED MEDICAL ASSOCIATES, LLC · U
- ComfortFoam/Ag Border — DERMARITE INDUSTRIES LLC · U
- Medline — MEDLINE INDUSTRIES, INC. · U
- NuMed Industries LLC. — Numed Industries, LLC · U
- Arthrex® — Arthrex, Inc. · U
- CalciCare — Hollister Incorporated · U
- ComfortFoam/Ag Border — DERMARITE INDUSTRIES 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Protect U Guard, Llc
Sources (1)
- FDA UDI 4aadf5ac-9e3d-4d2d-b3fb-c2d4b42a610d 35 fields · synced May 30, 2026