Customed 712057470015

• FDA 510(k) K953678 decided 2 Oct 1995 Active
• FDA GUDID UDI-DI M2089000792 listed 23 Sep 2016 Listed

1. 2 Oct 1995 Cleared FDA 510(k) K953678
2. 23 Sep 2016 Listed FDA GUDID M2089000792

Trade name

Customed

Generic name

Sterilization packaging, single-use

Model / Ref / Catalog

712057470015, 900079

Primary DI / UDI-DI

M2089000792

510(k) Number

K953678 ↗

FDA product code

FRG

GMDN term

Sterilization packaging, single-use

Device class

Class II

Regulation number

880.6850

GUDID distribution status

In Commercial Distribution

Category: Sterilization packaging, single-use

Other devices filed under FDA product code FRG (Wrap, Sterilization).

• G.E. Sterile, Percutaneous Cholangiographic Tray by GE MEDICAL SYSTEMS, INC.
• Durablue Sterilization Wrap by Cardinal Health, Medical Products and Services
• KimGuard One-Step Sterilization Wrap by Kimberly-Clark Health Care
• Pan Set by Sterile Design, Inc.
• Steri-Dent, Steri-Sure by Cpac, Inc.
• Adamco Dust Cover by Chase Mfg. Co.
• Turbett Surgical Instrument Pod (TS1500, TS1200, TS1000) by Turbett Surgical, LLC
• SteriTite Containers System & MediTray Products by CASE MEDICAL INC
• TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS by Advanced Sterilization Products, Inc.
• Sterile Pan Set by Medi-Plast Intl., Inc.

• Sterile Suture Removal Kit

  Class I

  FDA 510(k) K925015 Active Cleared 7 Jun 1993

• Customed 712057831816

  Class II

  FDA 510(k) K092338 Active Cleared 27 May 2011 GUDID on market

• Customed 712057102985

  Class I

  GUDID on market

• Customed 712057462213

  Class II

  FDA 510(k) K081633 Active Cleared 11 Aug 2008 GUDID on market

See all devices from Customed, Inc. →