Illuminating Bayonet EndoProbe® Handpiece

GUDID 00813125011772

IRIDEX CORPORATION

Ophthalmic laser system beam guide Ophthalmic laser system beam guide
Primary Device ID00813125011772
NIH Device Record Key2f5cca15-ae84-42af-85ee-c6a977abf095
Commercial Distribution StatusIn Commercial Distribution
Brand NameIlluminating Bayonet EndoProbe® Handpiece
Version Model Number65728-1
Company DUNS612920785
Company NameIRIDEX CORPORATION
Device Count1
DM Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Needle Gauge20 Gauge
Needle Gauge20 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100813125011772 [Package]
Contains: 00813125011789
Package: Box [6 Units]
In Commercial Distribution
GS100813125011789 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00813125011772]

Ethylene Oxide


[00813125011772]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-28

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