Arthrex® - NAV-X STEERABLE HOOK, MONOPOLAR, 220 MM - ARTHREX, INC.

Duns Number:131747628

Device Description: NAV-X STEERABLE HOOK, MONOPOLAR, 220 MM

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More Product Details

Catalog Number

AR-6528-02

Brand Name

Arthrex®

Version/Model Number

AR-6528-02

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

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

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

6c794078-7cbf-41bf-9450-379e2adeefdb

Public Version Date

March 18, 2021

Public Version Number

7

DI Record Publish Date

February 15, 2017

Additional Identifiers

Package DI Number

10888867039923

Quantity per Package

5

Contains DI Package

00888867039926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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