095196

GUDID 02816901021901

LEONI FIBER OPTICS, INC.

Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use
Primary Device ID02816901021901
NIH Device Record Keyefc147a0-18d6-4328-a216-dd9a002a8046
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLFS-940-SB
Catalog Number095196
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 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
GS100816901021903 [Primary]
GS101816901021902 [Package]
Contains: 00816901021903
Package: [5 Units]
In Commercial Distribution
GS102816901021901 [Package]
Contains: 01816901021902
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-30
Device Publish Date2019-08-22

Devices Manufactured by LEONI FIBER OPTICS, INC.

01816901023401 - NeuLight®2023-03-27
01816901023425 - NeuLight®2023-03-27
01816901023418 - NeuLight®2023-02-20
01816901023470 - Typenex Medical2023-02-13
01816901023708 - Typenex Medical2023-02-13
01816901023746 - NeuLight®2022-11-14
01816901023753 - NeuLight®2022-11-14
02816901023769 - NeuLight®2022-11-14

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