FDA UDI Not in Commercial Distribution 🇺🇸 United States

Repl. Cover (Dark Gray), SA-8Hr, VelaShape II

DI: 07290109950761 · Model: AS81221 · SYNERON MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Repl. Cover (Dark Gray), SA-8Hr, VelaShape II
Primary DI
07290109950761
Version / Model
AS81221
Catalog Number
AS81221
Company Name
SYNERON MEDICAL LTD
Labeler DUNS
532685716
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-26
Public Version
4
Public Version Date
2023-06-23
Public Version Status
Update
Public Device Record Key
e9e289a9-ad0f-4cac-a63d-5de5b012efe6
Distribution End Date
2023-06-22

Device Description

Repl. Cover (Dark Gray), SA-8Hr, VelaShape II

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NUV Massager, Vacuum, Light Induced Heating

GMDN Terms

Code Name
44832 Multi-modality skin contouring system

Identifiers

Type ID
Primary 07290109950761
Package 37290109950762
Package 17290109950768