Arthrex® - Anterolateral Pilon Fusion Plate, 5H, RT - ARTHREX, INC.

Duns Number:131747628

Device Description: Anterolateral Pilon Fusion Plate, 5H, RT

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More Product Details

Catalog Number

AR-8963ARF-05S

Brand Name

Arthrex®

Version/Model Number

AR-8963ARF-05S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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 Details

Product Code

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

132b4d00-3e80-42fe-a8ac-131db64a61c5

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

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