BenaCel C-002

• FDA 510(k) K090612 decided 24 Jul 2009 Active
• FDA GUDID UDI-DI D767B0102121 listed 24 Sep 2015 Listed

1. 24 Jul 2009 Cleared FDA 510(k) K090612
2. 24 Sep 2015 Listed FDA GUDID D767B0102121

Trade name

BenaCel

Generic name

General oral wound dressing, non-animal-derived, sterile

Model / Ref / Catalog

C-002, B01-0212

Primary DI / UDI-DI

D767B0102121

510(k) Number

K090612 ↗

FDA product code

MGQ

GMDN term

General oral wound dressing, non-animal-derived, sterile

Device class

U

GUDID distribution status

In Commercial Distribution

Category: General oral wound dressing, non-animal-derived, sterile

Other devices filed under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic).

• STERILE GAUZE PK STRIPS SAT W/CARR GEL WOUND DRESS by Carrington Laboratories, Inc.
• GLUCANPRO CREAM by Brennen Medical, LLC
• CURAFIL WOUND GEL DRESSING by Kendall Healthcare Products Co. Div.Of Tyco Health
• MODIFICATION TO WOUN'DRES by Coloplast Corp.
• AQUAFLO BTP HYDROGEL WOUND DRESSING by Sherwood Medical Co.
• ROYL-DERM WOUND HYDROGEL by Renaissance Medical, Inc.
• OSMOCYTE WOUND MANAGER SHEET DRESSING by Procyte Corp.
• CARRINGTON WOUND DRESSING 4X4(TM) by Carrington Laboratories, Inc.
• NORMLGEL 0.9% ISOTONIC SALINE GEL by Molnlycke Health Care, Inc.
• BIAFINE WOUND DRESSING EMULSION by Medix Pharmaceuticals Americas, Inc.

• Cytoflex Mesh M4-500

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  FDA 510(k) K021511 Active Cleared 6 Aug 2002 GUDID on market

• Cytoflex Resorb 20x25mm

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  FDA 510(k) K090083 Active Cleared 23 Mar 2009 GUDID on market

• Cytoflex Ti-enforced 25x30mm

  Class II

  FDA 510(k) K151344 Active Cleared 19 Nov 2015 GUDID on market

• Cytoflex Textured Tef-Guard TEX-200

  Class II

  FDA 510(k) K012144 Active Cleared 1 Oct 2001 GUDID on market

See all devices from Unicare Biomedical, Inc. →