External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima

GUDID 17290109952823

External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima

SYNERON MEDICAL LTD

Laser skin surface treatment system applicator
Primary Device ID17290109952823
NIH Device Record Key0a0b63c0-ca9a-4b2d-97c0-d6910d3fe36f
Commercial Distribution StatusIn Commercial Distribution
Brand NameExternal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
Version Model NumberKT77911
Company DUNS532685716
Company NameSYNERON MEDICAL LTD
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109952888 [Unit of Use]
GS117290109952823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-01-31

Devices Manufactured by SYNERON MEDICAL LTD

07290109952703 - SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III 2020-03-31 SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
07290109952857 - Intima Sterile 2 Internal + 1 External HP, Accessories Kit2020-02-10 Intima Sterile 2 Internal + 1 External HP, Accessories Kit
07290109952864 - eTwo System2020-02-10 eTwo System
17290109952724 - Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima2020-02-10 Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
17290109952823 - External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima2020-02-10External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
17290109952823 - External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima2020-02-10 External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
17290109950379 - Internal, CO2RE Intima2019-02-07 Internal, CO2RE Intima
07290109950167 - Purple swivel lens2019-02-07 Purple swivel lens
07290109950273 - Lens, Gold & Silver2019-02-07 Lens, Gold & Silver Assy, CO2RE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.