Catalog Number

CAT02009

Brand Name

NA

Version/Model Number

CAT02009

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 12, 2019

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

1772fb80-8cc1-47d1-adbb-0b585891f589

Public Version Date

June 12, 2019

Public Version Number

4

DI Record Publish Date

September 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-