Duns Number:171513125
Device Description: M6-C Implant Case Kit – Ancillary
Catalog Number
ICC-0000-10
Brand Name
M6-C
Version/Model Number
FG 0169
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
P170036
Product Code
MJO
Product Code Name
Prosthesis, Intervertebral Disc
Public Device Record Key
5056ddee-33cc-434e-9f2f-8c869971b74f
Public Version Date
April 28, 2022
Public Version Number
1
DI Record Publish Date
April 20, 2022
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |
| 3 | A medical device with high risk that requires premarket approval | 11 |