Slimline Sterilization Tray

GUDID 07290109140124

LUMENIS LTD.

General/multiple surgical solid-state laser system
Primary Device ID07290109140124
NIH Device Record Key9e4e0d75-a3fd-43b4-9dc5-990e26a4fd4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlimline Sterilization Tray
Version Model NumberSlimline Sterilization Tray
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone408-764-3000
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109140124 [Primary]
GS107290109144238 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-29
Device Publish Date2016-08-21

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

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