Identity
- Trade Name
- Surgaflex FDA UDI
- Generic Name
- Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sq in. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed boxes of 5. FDA UDI
- Model / Reference
- 91017 FDA UDI
- Description
- Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sq in. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed boxes of 5. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850019162288 FDA UDI
- 510(k) Number
- K153756 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent first aid dressing, hydrophilic-gel, 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
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 first aid dressing, hydrophilic-gel, antimicrobial
Surgaflex by Imbed Biosciences, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial.
- MEDLINE — MEDLINE INDUSTRIES, INC. · U
- MEDLINE — MEDLINE INDUSTRIES, INC. · U
- MEDLINE — MEDLINE INDUSTRIES, INC. · U
- MEDLINE — MEDLINE INDUSTRIES, INC. · U
- MEDLINE — MEDLINE INDUSTRIES, INC. · U
- MEDLINE — MEDLINE INDUSTRIES, INC. · U
- MEDLINE — MEDLINE INDUSTRIES, INC. · U
- MEDLINE — MEDLINE INDUSTRIES, INC. · U
Cleared under the same submission
K153756 also covers:
- Microlyte Ag VET — IMBED BIOSCIENCES, INC.
- Microlyte Ag VET — IMBED BIOSCIENCES, INC.
- Microlyte Matrix — IMBED BIOSCIENCES, INC.
- Microlyte Matrix — IMBED BIOSCIENCES, INC.
- Microlyte Matrix — IMBED BIOSCIENCES, INC.
- Microlyte Matrix — IMBED BIOSCIENCES, INC.
- Microlyte Matrix — IMBED BIOSCIENCES, INC.
- Microlyte Matrix — IMBED BIOSCIENCES, INC.
- Microlyte Matrix — IMBED BIOSCIENCES, INC.
- Microlyte Matrix — IMBED BIOSCIENCES, INC.
- Microlyte Matrix — IMBED BIOSCIENCES, INC.
- Microlyte Matrix — IMBED BIOSCIENCES, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Imbed Biosciences, Inc.
Sources (1)
- FDA UDI a5aafbfb-4957-4ba8-b1b2-5493e60cdc2c 36 fields · synced Jun 8, 2026