LithoWise

GUDID 00861062000342

940 micrometer laser fiber

FIBER OPTIC FABRICATIONS, INC.

General/multiple surgical laser system beam guide, single-use, sterile
Primary Device ID00861062000342
NIH Device Record Key76f8a47b-4ba8-4385-8172-9e15967ae09e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLithoWise
Version Model NumberLW-0004
Company DUNS879359610
Company NameFIBER OPTIC FABRICATIONS, INC.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100861062000342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


[00861062000342]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-22
Device Publish Date2018-07-22

On-Brand Devices [LithoWise]

00861062000342940 micrometer laser fiber
00861062000335550 micrometer laser fiber
00861062000328365 micrometer laser fiber
00861062000311272 micrometer laser fiber
00861062000359400 micrometer laser fiber

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