Catalog Number

530001

Brand Name

Top Shelf Orthopedics

Version/Model Number

530001

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)

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

0331cb07-339d-4b93-a385-3ae0a171e51b

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Package DI Number

10850016589009

Quantity per Package

6

Contains DI Package

00850016589002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-