Identity
- Trade Name
- RTD Wound Dressing EUDAMEDFDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
- Device Name
- RTD Wound Dressing EUDAMED
- Model / Reference
- RTD76040414 EUDAMED76040414 FDA UDI
Identifiers
- Catalog Number
- 76040414 FDA UDI
- Primary DI / UDI-DI
- 30856227004045 EUDAMEDFDA UDI
- Basic UDI-DI
- B-30856227004045 EUDAMED
- FDA Product Code
- FRO FDA UDI
- EMDN Code
- M04040602 POLYURETHANE DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED
- GMDN Term
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
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
No
FDA UDI
Category: Exudate-absorbent dressing, non-gel, antimicrobial
RTD Wound Dressing by Gwm Products, LLC — Class U — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gwm Products, LLC
Sources (2)
- FDA UDI 1e657e21-2ba1-49bb-af5b-c94ebff733fb 33 fields · synced Jun 19, 2026
- EUDAMED f796efdc-10ff-4971-9550-5571c2697f50 61 fields · synced Jun 19, 2026