Duns Number:808821883
Device Description: IDUO–IPOLY–7MM INSERT KIT–LEFT or right MEDIAL or lateral
Catalog Number
RBK0100700
Brand Name
iDuo® iPoly™ Insert Kit
Version/Model Number
RBK010070002
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
K093513
Product Code
NPJ
Product Code Name
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Public Device Record Key
6da28679-665c-41ad-bcb5-2de6445a906c
Public Version Date
August 15, 2022
Public Version Number
4
DI Record Publish Date
October 26, 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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1451 |