VanishPoint® 11091

• FDA 510(k) K970803 decided 29 May 1997 Active
• FDA GUDID UDI-DI 00613703110909 listed 22 Sep 2016 Listed

1. 29 May 1997 Cleared FDA 510(k) K970803
2. 22 Sep 2016 Listed FDA GUDID 00613703110909

Trade name

VanishPoint®

Generic name

Metered-delivery hypodermic syringe/needle

Model / Ref / Catalog

11091

Primary DI / UDI-DI

00613703110909

510(k) Number

K970803 ↗

FDA product code

MEG

GMDN term

Metered-delivery hypodermic syringe/needle

Device class

Class II

Regulation number

880.5860

GUDID distribution status

In Commercial Distribution

Category: Metered-delivery hypodermic syringe/needle

Other devices filed under FDA product code MEG (Syringe, Antistick).

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• safePICO70 956-612 by Radiometer Medical ApS
• OMI RETRACTABLE SAFETY SYRINGE by Vitalcare Group, Inc.
• micsafe 01 by Jiangsu Micsafe Medical Tehcnology Co., LTD.
• Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle by Yangzhou Medline Industry Co., Ltd.
• E.N.S.I. RETRACTABLE SAFETY SYRINGE by Ensi-Med International Pty., Ltd.
• MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE by Medsafe Technologies, LLC
• BECTON DICKINSON SYRINGE by Bd Becton Dickinson Vacutainer Systems Preanalytic
• BD SafetyGlide 305950 by Becton, Dickinson and Company
• TERUMO SURGUARD SAFETY SYRINGE by TERUMO MEDICAL CORPORATION

• VanishPoint Syringe

  Class IIa

  CE/MDR

• VanishPoint® 10154

  Class II

  FDA 510(k) K980069 Active Cleared 12 Feb 1998 GUDID on market

• EasyPoint® 82211 Open recall

  Class II

  CE/MDR FDA 510(k) K133635 Active Cleared 17 Jun 2014 +1authorizations

• VanishPoint® 10301

  Class II

  CE/MDR FDA 510(k) K946219 Active Cleared 28 Dec 1995 +1authorizations

See all devices from Retractable Technologies, Inc. →