Duns Number:317931954
Device Description: AK-ControlSil -2 mm-, size 40, silicone liner with distal connection, outer matrix without AK-ControlSil -2 mm-, size 40, silicone liner with distal connection, outer matrix without silicone strips, antibacterial finish
Catalog Number
60L50/40
Brand Name
AK-Control.Sil -2 mm-
Version/Model Number
60L50/40
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISS
Product Code Name
Prosthesis, Thigh Socket, External Component
Public Device Record Key
e59a031b-d180-4676-b11c-2ab9bf075e41
Public Version Date
November 12, 2020
Public Version Number
1
DI Record Publish Date
November 04, 2020
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 | 64 |