BenaCel C-003

• FDA 510(k) K090612 decided 24 Jul 2009 Active
• FDA GUDID UDI-DI D767B0103081 listed 18 Sep 2015 Listed

1. 24 Jul 2009 Cleared FDA 510(k) K090612
2. 18 Sep 2015 Listed FDA GUDID D767B0103081

Trade name

BenaCel

Generic name

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

Model / Ref / Catalog

C-003, B01-0308

Primary DI / UDI-DI

D767B0103081

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).

• BURNFREE PAIN RELIEVING GEL, MODEL 4B by Nortrade Medical, Inc.
• HylaGuard Moisturizing Cream by Founders Science Group, LLC
• DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING by Debusk Knitting Mills, Div. Deroyal Industries
• DCURASOL GEL WOUND DRESSING by DPT LABORATORIES, LTD.
• MODIFICATION OF BIONECT HYDROGEL FOAM by Fidia Pharmaceutical Corp.
• DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING by DEROYAL INDUSTRIES, INC.
• M-K HYDROGEL DRESSING by Mason-Keller Corp.
• IAMIN IMPREGNATED GAUZE DRESSING by Procyte Corp.
• SPARTA HYDROGEL WOUND DRESSING by Sparta Surgical Corp.
• BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD by Nortrade Medical, 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. →