G-Probe™ Illuminate Single

GUDID 00813125015701

IRIDEX CORPORATION

Ophthalmic laser system beam guide Ophthalmic laser system beam guide
Primary Device ID00813125015701
NIH Device Record Key09c9212d-0995-4202-a747-32460fad1b9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameG-Probe™ Illuminate Single
Version Model Number16200-1
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
Phone(800) 388-4747
Emailtechsupport@iridex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813125015701 [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

On-Brand Devices [G-Probe™ Illuminate Single]

0081312501570116200-1
0081312501536716000-1

Trademark Results [G-Probe]

Mark Image

Registration | Serial
Company
Trademark
Application Date
G-PROBE
G-PROBE
87732831 5529525 Live/Registered
IRIDEX Corporation
2017-12-22

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