Fiber Inserts for Laryngeal Probes (3 pk)

GUDID 17290109141463

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor
Primary Device ID17290109141463
NIH Device Record Keyd7e30ed3-d2de-4419-9bfc-4f50b8630799
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiber Inserts for Laryngeal Probes (3 pk)
Version Model Number14621
Company DUNS600166524
Company NameLUMENIS LTD.
Device Count3
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 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
Phone408-764-3000
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109141466 [Unit of Use]
GS117290109141463 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


[17290109141463]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-26
Device Publish Date2016-11-15

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.