Identity
- Trade Name
- Foundation DRS Solo FDA UDI
- Generic Name
- Wound regenerating polysaccharide agent FDA UDI
- Model / Reference
- FS1-0203 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850047730329 FDA UDI
- FDA Product Code
- FTM FDA UDIPMQ FDA UDIQSZ FDA UDIFRO FDA UDI
- GMDN Term
- Wound regenerating polysaccharide agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI864.9245 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 — 2 Centimeter FDA UDIWidth — 3 Centimeter FDA UDI
Category: Wound regenerating polysaccharide agent
Foundation DRS Solo by Bionova Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound regenerating polysaccharide agent.
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- 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
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 II | Pending data |
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Manufacturer
- Manufacturer
- Bionova Medical, Inc.
Sources (1)
- FDA UDI fa50ac98-74e9-4e63-9a84-53ec6b793ad8 34 fields · synced May 30, 2026