Duns Number:078582549
Device Description: Surgical Instrument- 10 mm Placer
Catalog Number
PLC-10
Brand Name
Cartiva SCI Placer
Version/Model Number
PLC-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
-
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
P150017
Product Code
QBO
Product Code Name
Instruments Designed For Press-Fit Osteochondral Implants
Public Device Record Key
e28dafb9-9877-4b72-96b1-7467ba2cade4
Public Version Date
June 23, 2020
Public Version Number
4
DI Record Publish Date
January 13, 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 | 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 |