Duns Number:010981554
Device Description: No change in DI justified in the CO. No form fit function, model or version changes trigg No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI
Catalog Number
-
Brand Name
Cellfina Motor Module Device and Package
Version/Model Number
CM1 Rev C, D, E
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OUP
Product Code Name
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Public Device Record Key
aaa4d431-3f96-4d7f-9275-1f057e9a18f3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 07, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |