Catalog Number

3910-000-100

Brand Name

NA

Version/Model Number

3910-000-100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2017

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HWQ

Product Code Name

PASSER

Public Device Record Key

d3726290-c673-41a8-a91d-2d19b36cb585

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

September 04, 2015

Package DI Number

34546540392320

Quantity per Package

5

Contains DI Package

04546540392329

Package Discontinue Date

March 09, 2017

Package Status

Not in Commercial Distribution

Package Type

pack