Duns Number:282651413
Device Description: BI-MENTUM dual mobility system - BI-MENTUM Plus Cup metal-back cementlessBI-MENTUM Plus Cu BI-MENTUM dual mobility system - BI-MENTUM Plus Cup metal-back cementlessBI-MENTUM Plus Cup has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium)
Catalog Number
-
Brand Name
BI-MENTUM Plus Cup
Version/Model Number
BI-MENTUM Plus Cup 43
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
LZO
Product Code Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Public Device Record Key
6a9b0053-1b61-40fc-8f9d-f7803a5d4ab6
Public Version Date
September 09, 2020
Public Version Number
2
DI Record Publish Date
January 15, 2019
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. | 206 |