Duns Number:532685716
Device Description: UltraShape System, Packaged for US
Catalog Number
FG71051USR
Brand Name
UltraShape system
Version/Model Number
FG71051USR
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
K141708
Product Code
OHV
Product Code Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Public Device Record Key
10d11a94-cdea-4ab5-92af-e36ab8301d54
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 25, 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. | 194 |