23G BriteLight™ EndoProbe® Single

GUDID 00851089000418

IRIDEX CORPORATION

Ophthalmic laser system beam guide
Primary Device ID00851089000418
NIH Device Record Key854f9c62-c0cd-441b-8ba6-8c73ba946c1e
Commercial Distribution StatusIn Commercial Distribution
Brand Name23G BriteLight™ EndoProbe® Single
Version Model Number14540-1
Company DUNS612920785
Company NameIRIDEX CORPORATION
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 388-4747
Emailtechsupport@iridex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851089000418 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by IRIDEX CORPORATION

00813125010584 - OMA (810 nm)2024-05-14 OMA, 810nm, for Zeiss Visu 150/200 Operating Microscope
00813125010591 - OMA (810 nm)2024-05-14 OMA, 810 nm, for Leica/Wild M650/M690 Operating Microscope
00813125010645 - OMA (810 nm)2024-05-14 OMA, 810 nm, for OPMI-6 Operating Microscope
00813125016975 - SLA EasyView™ (577 nm)2024-05-14 for Haag Streit 900 BM/BQ Slit Lamp
00813125016999 - SLA (577 nm)2024-05-14 for Zeiss 30 slit lamp or equivalent
00813125017019 - SLA (532 nm)2024-05-14 for Zeiss 30 CSO or equivalent
00813125010935 - SLA (810 nm)2024-05-10 SLA, 810 nm, for Haag Streit w/MM Slit Lamp
00813125011147 - SLA EasyFit™ (532 nm)2024-05-10 SLA EasyFit™, 532nm, for Zeiss 30 & Split-Mirror Slit Lamp

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