Identity
- Trade Name
- Dual-Dress 50 11x24 FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Foam Wound Dressing FDA UDI
- Model / Reference
- 2964 FDA UDI
- Description
- Foam Wound Dressing FDA UDI
Identifiers
- Catalog Number
- 2964 FDA UDI
- Primary DI / UDI-DI
- 00810050460118 FDA UDI
- 510(k) Number
- K990042 FDA UDI
- FDA Product Code
- MGP FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Classification
- Device Class
- U 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
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
Dimensions & Sizes
- Size
- Width — 11 Inch FDA UDILength — 24 Inch FDA UDIWidth — 28 Centimeter FDA UDILength — 61 Centimeter FDA UDI
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Dual-Dress 50 11x24 by Bio Med Sciences, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound-nonadherent dressing, absorbent, non-antimicrobial.
- Suprasorb — Huizhou Foryou Medical Devices Co., Ltd. · Class I
- Proximel Silicone Dressing 5x5 — HARTMANN USA INC. · Class I
- Healqu — HEALQU LLC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- Curity — Cardinalhealth · Class I
- 16PW - Class A Blue Metal Detectable - Poly White — Certified Safety Manufacturing, Inc. · U
- EMT - Class B Trauma - Bag — Certified Safety Manufacturing, Inc. · Class I
Cleared under the same submission
K990042 also covers:
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio Med Sciences, Inc.
Sources (1)
- FDA UDI 62117d73-1505-48e0-af45-2abc7bbb692c 37 fields · synced Jun 1, 2026