097326

GUDID 02816901021239

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable Urogenital surgical laser system beam guide, reusable
Primary Device ID02816901021239
NIH Device Record Key23343cf0-0212-45fc-b4fe-bb38f068bd80
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLFS-200
Catalog Number097326
Company DUNS039281260
Company NameLEONI FIBER OPTICS, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100816901021231 [Primary]
GS101816901021230 [Package]
Contains: 00816901021231
Package: [5 Units]
In Commercial Distribution
GS102816901021239 [Package]
Contains: 01816901021230
Package: [2 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-15
Device Publish Date2016-11-04

Devices Manufactured by LEONI FIBER OPTICS, INC.

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01816901023708 - Typenex Medical2023-02-13
01816901023746 - NeuLight®2022-11-14
01816901023753 - NeuLight®2022-11-14
02816901023769 - NeuLight®2022-11-14

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