Customed 712057712784

• FDA 510(k) K050887 decided 11 Jul 2005 Active
• FDA GUDID UDI-DI M20890027843 listed 23 Sep 2016 Listed

1. 11 Jul 2005 Cleared FDA 510(k) K050887
2. 23 Sep 2016 Listed FDA GUDID M20890027843

Trade name

Customed

Generic name

Vaginal speculum, single-use

Model / Ref / Catalog

712057712784, 9002784

Primary DI / UDI-DI

M20890027843

510(k) Number

K050887 ↗

FDA product code

HIB

GMDN term

Vaginal speculum, single-use

Device class

Class II

Regulation number

884.4530

GUDID distribution status

In Commercial Distribution

Category: Vaginal speculum, single-use

Other devices filed under FDA product code HIB (Speculum, Vaginal, Nonmetal).

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• DISPOSABLE PLASTIC VAGINAL SPECULA by Zinnanti Surgical Instruments, Inc.
• AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 by C.I.S.A. Import Export C/O Larson and Taylor
• JFord Speculum Sleeve™ by Ford Medtech, LLC
• KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM by Welch Allyn, Inc.
• KENTEX DISPOSABLE VAGINAL SPECULUM by KENTRON HEALTH CARE, INC.
• GRAVESPEC by ADEPT-MED INTL., INC.
• POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM by Advanced Urological Developments
• KOLPLAST VAGINAL SPECULUM by Kolplast Comercial E Industrial Ltda
• DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE by Dynarex Corp.

• 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. →