Duns Number:131747628
Device Description: PROWICK SHOULDER DRESSING & COLD THERAPY
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
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
NAC
Product Code Name
Dressing, wound, hydrophilic
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
Package DI Number
10888867020198
Quantity per Package
10
Contains DI Package
00888867020191
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
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 |