Duns Number:131747628
Device Description: DUALWAVE WITH FOOT PEDAL SET
Catalog Number
AR-6480-SF
Brand Name
Arthrex®
Version/Model Number
AR-6480-SF
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
-
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
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
6b6270b4-26bf-4d49-a507-3934c5fd7325
Public Version Date
March 05, 2020
Public Version Number
5
DI Record Publish Date
February 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |