FDA UDI Not in Commercial Distribution 🇺🇸 United States

UltraShape Power System, Packaged

DI: 07290109952741 · Model: FG71481CA · SYNERON MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
UltraShape Power System, Packaged
Primary DI
07290109952741
Version / Model
FG71481CA
Catalog Number
FG71481CA
Company Name
SYNERON MEDICAL LTD
Labeler DUNS
532685716
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-03-26
Public Version
3
Public Version Date
2023-06-22
Public Version Status
Update
Public Device Record Key
961fdcee-86b7-40e4-b66d-32ed73142d3f
Distribution End Date
2023-06-21

Device Description

UltraShape Power System Canada, Packaged.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

GMDN Terms

Code Name
45591 Ultrasonic body contouring system

Identifiers

Type ID
Primary 07290109952741