Catalog Number

375-534-000

Brand Name

N/A

Version/Model Number

N/A

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

K012635,K012635

Product Code

HRX

Product Code Name

ARTHROSCOPE

Public Device Record Key

caeca9ca-b671-4be4-b564-38c2ec5bca55

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

30885825014378

Quantity per Package

5

Contains DI Package

00885825014377

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack