Catalog Number

530016

Brand Name

Top Shelf Orthopedics

Version/Model Number

530016

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

KQZ

Product Code Name

Component, Traction, Non-Invasive

Public Device Record Key

40ecb403-b02f-4ecc-acd1-04e1581a959a

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Package DI Number

10850016589047

Quantity per Package

5

Contains DI Package

00850016589040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-