Catalog Number

PNS100-1

Brand Name

ProTector

Version/Model Number

PNS100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K052725,K052725,K052725

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

4c1d66fd-45de-455e-a7da-a1c8a6215dfe

Public Version Date

November 01, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

H816PNS1002

Quantity per Package

10

Contains DI Package

H816PNS1001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Box