Burnshield 550060F

• FDA 510(k) K943728 decided 27 Sep 1994 Active
• FDA GUDID UDI-DI 06007645006347 listed 11 Nov 2020 Listed

1. 27 Sep 1994 Cleared FDA 510(k) K943728
2. 11 Nov 2020 Listed FDA GUDID 06007645006347

Trade name

Burnshield

Generic name

Synthetic polymer burn dressing, gel-coated

Model / Ref / Catalog

550060F

Primary DI / UDI-DI

06007645006347

FDA product code

MGQ

GMDN term

Synthetic polymer burn dressing, gel-coated

Device class

U

GUDID distribution status

In Commercial Distribution

Size

Length — 100 Millimeter

Width — 100 Millimeter

Weight — 40 Gram

Category: Synthetic polymer burn dressing, gel-coated

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

• NEUFINISH RESURFACING CREAM by Neutrogena Corp.
• BETA GLUCAN GEL (MACROPRO GEL) by Brennen Medical, LLC
• BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS by Levtrade Intl. (Pty), Ltd.
• STERILE WOUND HYDROGEL DRESSING by Renaissance Pharmaceutical, Inc.
• BIONECT CREAM by Fidia Pharmaceutical Corp.
• MODIFICATION OF BIONECT CLEAR HYDROGEL by Fidia Pharmaceutical Corp.
• HYDRO-S WOUND GEL by Hymedix Intl., Inc.
• ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 by Acrymed, Inc.
• STERIGAUZE GEL DRESSING by Acacia Laboratories, Inc.
• HYCOAT by The Hymed Group Corp.

• Medisafe

  Class IIb

  CE/MDD

• Burnshield

  Class IIb

  CE/MDD

• Mundial

  Class IIb

  CE/MDD

• Burnshield 881060

  Unclassified

  FDA 510(k) K943728 Active Cleared 27 Sep 1994 GUDID on market

See all devices from Burnshield (Pty) Ltd →