FemTouch™ Fine Focus Disposable Tips

GUDID 07290109143323

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID07290109143323
NIH Device Record Key3c3d0f8b-8243-4659-9fcc-cd6b298f38fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameFemTouch™ Fine Focus Disposable Tips
Version Model NumberFemTouch™ Fine Focus Disposable Tips
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 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
GS107290109143323 [Primary]
GS117290109143320 [Package]
Package: [10 Units]
In Commercial Distribution

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 Date2020-12-18
Device Publish Date2020-12-10

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