NA - 9MM FEMORAL INDEX GUIDE - STRYKER CORPORATION

Duns Number:187502109

Device Description: 9MM FEMORAL INDEX GUIDE

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More Product Details

Catalog Number

234-500-207

Brand Name

NA

Version/Model Number

234-500-207

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 13, 2020

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

NBH

Product Code Name

ACCESSORIES,ARTHROSCOPIC

Device Record Status

Public Device Record Key

eb8b9930-57f6-4888-b2d9-10737acc7af7

Public Version Date

November 13, 2020

Public Version Number

6

DI Record Publish Date

September 09, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60