Catalog Number

6207-097-101S1

Brand Name

Stryker Performance Series

Version/Model Number

6207097101S1

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

DWH

Product Code Name

BLADE, SAW, SURGICAL, CARDIOVASCULAR

Public Device Record Key

b0f2ed9d-46c8-4f50-aed3-dcffc641cc6c

Public Version Date

January 17, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2018

Package DI Number

37613154501145

Quantity per Package

10

Contains DI Package

07613154501144

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack