Catalog Number

CS003R

Brand Name

Adjustable Neoprene Chinstrap Regular

Version/Model Number

CS003R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BTK

Product Code Name

Strap, Head, Gas Mask

Public Device Record Key

fa39017b-a501-48e3-abb5-a0185cc869bb

Public Version Date

September 10, 2018

Public Version Number

3

DI Record Publish Date

May 24, 2018

Package DI Number

10848530080058

Quantity per Package

100

Contains DI Package

00848530080051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-