Duns Number:079118736
Device Description: TL PLASMA STR LONG SIZE 1 IMPLANT PARTNERS™
Catalog Number
PRTLSL21WD
Brand Name
Implant Partners
Version/Model Number
PRTLSL21WD
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K140676,K140676
Product Code
JDI
Product Code Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Public Device Record Key
c3e96ee4-a78e-4939-8e06-2f60e7046274
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 23, 2015
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 | 7823 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12222 |
| 3 | A medical device with high risk that requires premarket approval | 109 |