Customed 712057712783

• FDA 510(k) K050887 decided 11 Jul 2005 Active
• FDA GUDID UDI-DI M20890027833 listed 23 Sep 2016 Listed

1. 11 Jul 2005 Cleared FDA 510(k) K050887
2. 23 Sep 2016 Listed FDA GUDID M20890027833

Trade name

Customed

Generic name

Vaginal speculum, single-use

Model / Ref / Catalog

712057712783, 9002783

Primary DI / UDI-DI

M20890027833

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).

• AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 by C.I.S.A. Import Export C/O Larson and Taylor
• VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L by MEDICAL ACTION INDUSTRIES INC.
• MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 by Medscand AB
• VAGINAL SPECULUM - DISPOSABLE by Galenica Enterprises, Inc.
• GYNECOLOGIC EXAMINATION KIT by A & A Medical, Inc.
• SPECULUM, VAGINAL, NONMETAL by Welch Allyn, Inc.
• PHYSICIAN'S CHOICE by Advance Medical Device, Inc.
• PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS by Playtex Products, Inc.
• INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION by Olsen Electrosurgical, Inc.
• DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE by Dukal LLC

• 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. →