FDA UDI Not in Commercial Distribution 🇺🇸 United States

SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III

DI: 07290109952697 · Model: AS83333 · SYNERON MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III
Primary DI
07290109952697
Version / Model
AS83333
Catalog Number
AS83333
Company Name
SYNERON MEDICAL LTD
Labeler DUNS
532685716
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-06-01
Public Version
6
Public Version Date
2023-10-17
Public Version Status
Update
Public Device Record Key
e470be81-b676-46cb-a015-c60c122f3a14
Distribution End Date
2023-10-16

Device Description

SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III

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
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
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
44832 Multi-modality skin contouring system

Identifiers

Type ID
Package 17290109952694
Primary 07290109952697

Premarket Submissions

Submission Number Supplement Number
K122579 000