Duns Number:097664937
Device Description: For connecting Double Pump RF to S&N Dyonics RF, ArthroCare Atlas, ArthroCare Quantum and
Catalog Number
-
Brand Name
RF Cable A1
Version/Model Number
1402008
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
K093409
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
2dd3ccf9-e8e7-4507-8f1e-8b4b550bba69
Public Version Date
May 27, 2021
Public Version Number
4
DI Record Publish Date
March 17, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 36 |