Duns Number:282651413
Device Description: BI-MENTUM dual mobility system -BI-MENTUM PE Liner polyethylene liner
Catalog Number
-
Brand Name
BI-MENTUM PE Liner
Version/Model Number
BI-MENTUM PE Liner 22,2 / 41
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
eb9bfbdf-4b10-41fc-9210-0c64778615a0
Public Version Date
February 15, 2019
Public Version Number
1
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 |