Aramark 901138

• FDA 510(k) K943728 decided 27 Sep 1994 Active
• FDA GUDID UDI-DI 00830868000030 listed 1 Jun 2022 Listed

1. 27 Sep 1994 Cleared FDA 510(k) K943728
2. 1 Jun 2022 Listed FDA GUDID 00830868000030

Trade name

Aramark

Generic name

Synthetic polymer burn dressing, gel-coated

Model / Ref / Catalog

901138

Primary DI / UDI-DI

00830868000030

FDA product code

MGQ

GMDN term

Synthetic polymer burn dressing, gel-coated

Device class

U

GUDID distribution status

In Commercial Distribution

Size

Weight — 40 Gram

Width — 100 Millimeter

Length — 100 Millimeter

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).

• DERMAPLEX HYDROGEL WOUND DRESSING (2X2, 4X4, 4X8, 6X10) by Richard Hamer Assoc., Inc.
• IAMIN WET DRESSING (COPPER-SALINE) by Procyte Corp.
• B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING by B. Braun Medical, Inc.
• PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING by Marketing Perspectives
• HYDROGEL DRESSING by O.R. Resources, Inc.
• PHYTACARE ALGINATE HYDROGEL WOUND DRESSING by Phytatek Laboratories, Inc.
• WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL by Renaissance Pharmaceutical, Inc.
• XYLOS XCELL ANTIMICROBIAL DRESSING by Xylos Corporation
• SWEEN WOUND CARE-COLLAGEN WOUND DRESSING by Sween Corp.
• COLLATEK HYDROGEL by Biocore Medical Technologies, Inc.

• 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 →