Duns Number:989365556
Device Description: ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIG ACTIS TOTAL HIP SYSTEM ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS HIGH COLLARLESS SIZE 5
Catalog Number
101022050
Brand Name
ACTIS
Version/Model Number
1010-22-050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
KWL
Product Code Name
Prosthesis, hip, hemi-, femoral, metal
Public Device Record Key
918bb1b1-6047-4a77-9545-3a1e47cc5b97
Public Version Date
July 26, 2021
Public Version Number
1
DI Record Publish Date
July 17, 2021
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 | 3549 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2188 |
| 3 | A medical device with high risk that requires premarket approval | 418 |