Catalog Number

N/A

Brand Name

RETRA

Version/Model Number

5900

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

NBH

Product Code Name

Accessories, Arthroscopic

Public Device Record Key

9c3f6cd6-c108-4039-9c66-6f4b48836c0a

Public Version Date

November 17, 2020

Public Version Number

1

DI Record Publish Date

November 09, 2020

Package DI Number

00857915007590

Quantity per Package

5

Contains DI Package

00857915007583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-