23-27G Angled 45° EndoProbe® Single

GUDID 00851089000319

IRIDEX CORPORATION

Ophthalmic laser system beam guide
Primary Device ID00851089000319
NIH Device Record Key556928ef-043e-42c1-8044-a3362e3db073
Commercial Distribution StatusIn Commercial Distribution
Brand Name23-27G Angled 45° EndoProbe® Single
Version Model Number14400-1
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
GS100851089000319 [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

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