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Benacel Plus

FDA UDI

Class U (US FDA UDI)

by Unicare Biomedical, Inc.

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
10x20mm 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
B02-2610 FDA UDI
Primary DI / UDI-DI
D767B0226101 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.

Cleared under the same submission

K080532 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unicare Biomedical, Inc.

Sources (1)

  • FDA UDI b07c36cf-1517-4d44-a022-b8387dc64c66 37 fields · synced Jun 1, 2026