Duns Number:078582549
Device Description: Surgical Instrument Set- 8 mm Disposable
Catalog Number
MTS-08
Brand Name
Cartiva Disposable Instrument Set
Version/Model Number
MTS-08
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
be5f08bc-ef31-4df2-9c9b-0a5690fc39d4
Public Version Date
December 23, 2019
Public Version Number
1
DI Record Publish Date
December 13, 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 |
|---|---|---|
| 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 |