BenaCel C-004

• FDA 510(k) K090612 decided 24 Jul 2009 Active
• FDA GUDID UDI-DI D767B0104081 listed 23 Jul 2021 Listed

1. 24 Jul 2009 Cleared FDA 510(k) K090612
2. 23 Jul 2021 Listed FDA GUDID D767B0104081

Trade name

BenaCel

Generic name

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

Model / Ref / Catalog

C-004, B01-0408

Primary DI / UDI-DI

D767B0104081

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).

• BIONECT HYDROGEL SPRAY by Fidia Pharmaceutical Corp.
• HYDRODERM GEL WOUND DRESSING by Wilshire Medical Products
• BRENNEN MEDICAL GLUCAN II WOUND DRESSING by Brennen Medical, LLC
• DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING by Wilshire Medical Products
• SWEEN WOUN'DRES by Coloplast Corp.
• CARRASYN HYDROGEL WOUND DRESSING, CARRAGAUZE PADS, CARRAGAUZE STRIPS, CARRASORB M FDG by Carrington Laboratories, Inc.
• X-CELL WOUND DRESSING by Xylos Corporation
• MPM HYDROGEL DRESSING (NON-STERILE) by MPM MEDICAL
• IAMIN GEL WOUND DRESSING by Procyte Corp.
• BURN-AID HYDROGEL, BURN DRESSING, BURN BLANKET by Medtrak Intl., Inc.

• Cytoflex Mesh M4-500

  Class II

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

• BenaCel C-002

  Unclassified

  FDA 510(k) K090612 Active Cleared 24 Jul 2009 GUDID on market

• Cytoflex Resorb 20x25mm

  Class II

  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

See all devices from Unicare Biomedical, Inc. →