Catalog Number

00-1232-031-00

Brand Name

N/A

Version/Model Number

00-1232-031-00

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"

Yes

For Single-Use

-

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

HST

Product Code Name

Apparatus, Traction, Non-Powered

Public Device Record Key

45f485c7-96df-4e50-969c-91fa090603ab

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-