Standard Hand-piece packing Assy, CO2RE AS85421

GUDID 07290109950754

Standard Hand-piece packing Assy, CO2RE

SYNERON MEDICAL LTD

Dermatological carbon dioxide laser system

Primary Device ID	07290109950754
NIH Device Record Key	e07390eb-a9ea-4db8-a93a-b125413dc9de
Commercial Distribution Status	In Commercial Distribution
Brand Name	Standard Hand-piece packing Assy, CO2RE
Version Model Number	AS85421
Catalog Number	AS85421
Company DUNS	532685716
Company Name	SYNERON MEDICAL LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109950754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151655
Premarket Notification: K181523

FDA Product Code

GEX	Powered Laser Surgical Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

[07290109950754]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-02-07
Device Publish Date	2016-09-21

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 Kit	2020-02-10 Intima Sterile 2 Internal + 1 External HP, Accessories Kit
07290109952864 - eTwo System	2020-02-10 eTwo System
17290109952724 - Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima	2020-02-10 Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
17290109952823 - External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima	2020-02-10 External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
17290109950379 - Internal, CO2RE Intima	2019-02-07 Internal, CO2RE Intima
07290109950167 - Purple swivel lens	2019-02-07 Purple swivel lens
07290109950273 - Lens, Gold & Silver	2019-02-07 Lens, Gold & Silver Assy, CO2RE

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