BenaCel C-001

• FDA 510(k) K090612 decided 24 Jul 2009 Active
• FDA GUDID UDI-DI D767B0101081 listed 24 Sep 2015 Listed

1. 24 Jul 2009 Cleared FDA 510(k) K090612
2. 24 Sep 2015 Listed FDA GUDID D767B0101081

Trade name

BenaCel

Generic name

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

Model / Ref / Catalog

C-001, B01-0108

Primary DI / UDI-DI

D767B0101081

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).

• DERMAPLEX HYDROGEL WOUND DRESSING by Maxxim Medical
• MACROPRO GEL by Brennen Medical, LLC
• HYLATOPIC EMOLLIENT FOAM by Collegium Pharmaceutical Incorporated
• HYPERGEL 20% HYPERTONIC SALINE GEL by Molnlycke Health Care, Inc.
• MPM GELPAD (HYDROGEL SATURATED STERILE GAUZE PADS) by Marketing Professionals IN Medicine, Inc.
• WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL by Renaissance Medical, Inc.
• FLOWGEL(R) TOPICAL WOUND DRESSING by Mediventures, Inc.
• NU-GEL * WOUND DRESSING by Johnson & Johnson Medical, Inc.
• MPM HYDROGEL SATURATED DRESSING by MPM MEDICAL
• BIONECT CLEAR HYDROGEL by Fidia Pharmaceutical Corp.

• 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. →