Arthrex® - IBAL TKA TIB BRNG TRL CR + SZ 8,10MM - ARTHREX, INC.

Duns Number:131747628

Device Description: IBAL TKA TIB BRNG TRL CR + SZ 8,10MM

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More Product Details

Catalog Number

AR-603-A810

Brand Name

Arthrex®

Version/Model Number

AR-603-A810

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

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

a96b5ced-350d-4513-97a2-8e1bee4aa9c3

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

June 02, 2018

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