Duns Number:078582549
Device Description: Surgical Instrument Set- 10 mm
Catalog Number
MTK-10
Brand Name
Cartiva Disposable Instrument Set
Version/Model Number
MTK-10
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
QBO
Product Code Name
Instruments Designed For Press-Fit Osteochondral Implants
Public Device Record Key
a8ca9813-4c7d-4aea-a0c0-6b8886ac491f
Public Version Date
February 07, 2019
Public Version Number
2
DI Record Publish Date
July 16, 2018
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |
| 3 | A medical device with high risk that requires premarket approval | 4 |