Arthrex® - SIZE 21 LEG, GLENOID TARGETER - ARTHREX, INC.

Duns Number:131747628

Device Description: SIZE 21 LEG, GLENOID TARGETER

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More Product Details

Catalog Number

AR-5400-21

Brand Name

Arthrex®

Version/Model Number

AR-5400-21

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

KWS

Product Code Name

PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Device Record Status

Public Device Record Key

7feddb79-dadb-4653-a346-e80ee8c873f5

Public Version Date

February 24, 2020

Public Version Number

1

DI Record Publish Date

February 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARTHREX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6506
2 A medical device with a moderate to high risk that requires special controls. 3411
3 A medical device with high risk that requires premarket approval 1
U Unclassified 2