Duns Number:313267265
Device Description: IntraBlock™ TwinStem™ non-cemented size 8.75 Standard 12/14 TiAl6V4 ELI TPS-Coating steril IntraBlock™ TwinStem™ non-cemented size 8.75 Standard 12/14 TiAl6V4 ELI TPS-Coating sterile
Catalog Number
HR35008
Brand Name
IntraBlock™ TwinStem™
Version/Model Number
size 8.75 Standard
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 13, 2021
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
5d0140dc-97f6-48cd-a4d1-720faf7a439e
Public Version Date
December 14, 2021
Public Version Number
5
DI Record Publish Date
January 01, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 328 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1327 |
| U | Unclassified | 13 |