Catalog Number

-

Brand Name

Stryker

Version/Model Number

375-953-012

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

K172092,K172092,K172092

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

cc7e0d42-d1df-4827-8630-bd699dccf32a

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

December 13, 2019

Package DI Number

10810041636154

Quantity per Package

5

Contains DI Package

00810041636157

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box