Duns Number:171513125
Device Description: Fin Cutter, 7LL (7mm H x 17mm W x 16mm D), G6
Catalog Number
CIC-717L-06
Brand Name
M6-C
Version/Model Number
FA 0193-08
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
-
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
QLQ
Product Code Name
Manual Instruments Designed For Total Disc Replacement Device
Public Device Record Key
7da4711c-c7d2-4037-90e3-caf776e0df1c
Public Version Date
October 19, 2020
Public Version Number
2
DI Record Publish Date
March 01, 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 | 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 |