Catalog Number

CS007-ADJ

Brand Name

Sunset Ruby Style Chin Strap – Fully Adjustable

Version/Model Number

CS007-ADJ

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

-

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

3c70c66d-48ae-49ab-bf2f-a0db29ad4320

Public Version Date

October 18, 2018

Public Version Number

1

DI Record Publish Date

September 17, 2018

Package DI Number

10848530082182

Quantity per Package

90

Contains DI Package

00848530082185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-