Multi-Application Handpiece Set

GUDID 07290109141534

Additional DM UDI: 07290109144146 07290109144153 07290109144160 07290109144016 07290109144184 07290109144191 07290109144207 07290109144214 07290109144221

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece Surgical laser system beam-focus handpiece
Primary Device ID07290109141534
NIH Device Record Key22e5ade8-052d-4032-9bec-798621e866e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-Application Handpiece Set
Version Model NumberMulti-Application Handpiece Set
Company DUNS600166524
Company NameLUMENIS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109141534 [Primary]
GS107290109144139 [Direct Marking]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


[07290109141534]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-08-28

Devices Manufactured by LUMENIS LTD.

07290118853701 - Lumenis Pulse 60H, 60Hz2023-12-18
07290109144924 - Stellar SapphireCool LG 6mm2023-08-16
07290109144931 - Stellar SapphireCool LG 15x352023-08-16
07290109144948 - Stellar SapphireCool LG 8x152023-08-16
07290109146676 - SurgiTouch Scanner 2022-09-30
07290109146133 - UltraPulse® DUO2022-09-28 UltraPulse DUO
07290109147055 - VersaPulse PowerSuite 80/100W2022-09-27
07290109147062 - VersaPulse PowerSuite 80/100W2022-09-27

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