Arthrex® - PROWICK SHOULDER DRESSING & COLD THERAPY - ARTHREX, INC.

Duns Number:131747628

Device Description: PROWICK SHOULDER DRESSING & COLD THERAPY

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More Product Details

Catalog Number

AR-1625P

Brand Name

Arthrex®

Version/Model Number

AR-1625P

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

NAC

Product Code Name

Dressing, wound, hydrophilic

Device Record Status

Public Device Record Key

f6cfd904-7212-45e0-906b-d6bd40ebec80

Public Version Date

February 25, 2021

Public Version Number

4

DI Record Publish Date

August 03, 2018

Additional Identifiers

Package DI Number

10888867020198

Quantity per Package

10

Contains DI Package

00888867020191

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