AtoN Keywest Headlight without Fiber Optic Cable

GUDID 00851610007091

Light, Surgical, Endoscopic, Accessory

LONG ISLAND TECH

Endoscopic light source, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered Endoscopic light source unit, line-powered
Primary Device ID00851610007091
NIH Device Record Keydea39f3b-6e73-407d-9b23-a81889425c22
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtoN Keywest Headlight without Fiber Optic Cable
Version Model NumberP003267
Company DUNS030256600
Company NameLONG ISLAND TECH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851610007091 [Primary]

FDA Product Code

FSWLight, Surgical, Endoscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-21
Device Publish Date2016-09-02

Devices Manufactured by LONG ISLAND TECH

00851610007220 - Pharos HD Headcam2021-06-15 Surgical Camera & Light
00851610007299 - Fiji Headband2021-06-15 Surgical Headlight Accessory
00851610007336 - Pharos HD CCU2021-06-15 Surgical Camera & Light
00851610007190 - Dover Headlight Optic2020-12-29 Light, Surgical, Accessory
00851610007206 - Bristol Headlight Optic2020-12-29 Light, Surgical, Accessory
00851610007213 - Daymark Headlight Optic2020-12-29 Light, Surgical, Accessory
00851610007268 - Dover Holster2020-12-29
00851610007275 - Bristol Holster2020-12-29 Light & Surgical Accessory

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