Identity
- Trade Name
- Foundation DRS+ Duo FDA UDI
- Generic Name
- Wound regenerating polysaccharide agent FDA UDI
- Device Name
- Perforated FDA UDI
- Model / Reference
- 902-1025 FDA UDI
- Description
- Perforated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850047730176 FDA UDI
- 510(k) Number
- K240298 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound regenerating polysaccharide agent 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
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
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDIWidth — 25 Centimeter FDA UDI
Category: Wound regenerating polysaccharide agent
Foundation DRS+ Duo by Bionova Medical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound regenerating polysaccharide agent.
- Talymed 3 cm x 3 cm — MARINE POLYMER TECHNOLOGIES, INC. · U
- Talymed dressing 5 cm x 5 cm — MARINE POLYMER TECHNOLOGIES, INC. · U
- Talymed 10 cm x 10 cm — MARINE POLYMER TECHNOLOGIES, INC. · U
- Foundation DRS Solo — BIONOVA MEDICAL, INC. · Class II
- Foundation DRS Solo — BIONOVA MEDICAL, INC. · Class II
- Foundation DRS Solo — BIONOVA MEDICAL, INC. · Class II
- Foundation DRS+ Duo — BIONOVA MEDICAL, INC. · U
- Foundation DRS Solo — BIONOVA MEDICAL, INC. · Class II
Cleared under the same submission
K240298 also covers:
- Foundation DRS+ Duo — BIONOVA MEDICAL, INC.
- Foundation DRS+ Duo — BIONOVA MEDICAL, INC.
- Foundation DRS+ Duo — BIONOVA MEDICAL, INC.
- Foundation DRS+ Duo — BIONOVA MEDICAL, INC.
- Foundation DRS+ Duo — BIONOVA MEDICAL, INC.
- Foundation DRS+ Duo — BIONOVA MEDICAL, INC.
- Foundation DRS+ Duo — BIONOVA MEDICAL, INC.
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 |
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Manufacturer
- Manufacturer
- Bionova Medical, Inc.
Sources (1)
- FDA UDI 39efe291-6257-44eb-8529-1717850b04a5 36 fields · synced May 30, 2026