ProTector PNS100

• FDA 510(k) K052725 decided 28 Dec 2005 Active
• FDA GUDID UDI-DI H816PNS1001 listed 23 Sep 2016 Listed

1. 28 Dec 2005 Cleared FDA 510(k) K052725
2. 23 Sep 2016 Listed FDA GUDID H816PNS1001

Trade name

ProTector

Generic name

Surgical instrument containment holder, single-use, non-sterile

Model / Ref / Catalog

PNS100, PNS100-1

Primary DI / UDI-DI

H816PNS1001

510(k) Number

K052725 ↗

FDA product code

FMI

GMDN term

Surgical instrument containment holder, single-use, non-sterile

Device class

Class II

Regulation number

880.5570

GUDID distribution status

In Commercial Distribution

Category: Surgical instrument containment holder, single-use, non-sterile

Other devices filed under FDA product code FMI (Needle, Hypodermic, Single Lumen).

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• B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS by Med-Safe Systems, Inc.
• 305127 by Becton, Dickinson and Company
• MEDLINE HYPODERMIC NEEDLES by MEDLINE INDUSTRIES, INC.
• GE STERILE ARTHROGRAM TRAY by GE MEDICAL SYSTEMS, INC.
• K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall by Terumo Europe N.V.
• LUER ACCESS UNIVERSAL VIAL ADAPTER by Baxter Healthcare Corp
• HYPODERMIC NEEDLES by Ava Medical Products of Canada, Inc.
• THE VAULT by Stik Stoppers, Inc.
• Sterile Hypodermic Needles for Single Use by Azur Medical Company, Inc.

• ProView Plus PM3590

  Class II

  FDA 510(k) K953829 Active Cleared 9 Nov 1995 GUDID on market

• V-Cide VC338

  Class II

  FDA 510(k) K970726 Active Cleared 18 May 1998 GUDID on market

• Shield PFL008

  Class II

  FDA 510(k) K890128 Active Cleared 14 Feb 1989 GUDID on market

• ProTector PNS500

  Class II

  FDA 510(k) K052725 Active Cleared 28 Dec 2005 GUDID on market

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