Identity
- Trade Name
- Benacel Plus FDA UDI
- Generic Name
- Plant polysaccharide haemostatic agent, bioabsorbable FDA UDI
- Device Name
- BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks. FDA UDI
- Model / Reference
- 5x10cm FDA UDI
- Description
- BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks. FDA UDI
Identifiers
- Catalog Number
- B02-1010 FDA UDI
- Primary DI / UDI-DI
- D767B0210101 FDA UDI
- 510(k) Number
- K080532 FDA UDI
- FDA Product Code
- QSY FDA UDI
- GMDN Term
- Plant polysaccharide haemostatic agent, bioabsorbable 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
Yes
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: Plant polysaccharide haemostatic agent, bioabsorbable
Benacel Plus by Unicare Biomedical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Plant polysaccharide haemostatic agent, bioabsorbable.
- EndoClot PHS — EndoClot Plus, Inc.
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD · U
- SURGICEL FIBRILLAR — Ethicon Sàrl · Class III
- StopsBleeding™ — Coag Medical, LLC · U
- SURGICEL FIBRILLAR — Ethicon Inc. · Class III
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD · U
- BleedStop™ — Coag Medical, LLC · U
- WoundClot Hemostatic Gauze — CORE SCIENTIFIC CREATIONS LTD · U
Cleared under the same submission
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
- Unicare Biomedical, Inc.
Sources (1)
- FDA UDI 9ded31fe-83cb-46e7-96d0-24814866a839 37 fields · synced Jun 8, 2026