IBEX 2-step LED slit lamp

GUDID 00869228000427

IBEX Slit Lamps are specialized LED illuminated biomicroscope that provide a stereoscopic magnified view of the eye structures in crystal clear detail, enabling anatomical diagnoses to be made for a variety of eye conditions.

Trevi Technology, Inc.

Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination Ophthalmic slit lamp, examination
Primary Device ID00869228000427
NIH Device Record Key98c1a98d-a508-4710-b0fb-6a649067bf28
Commercial Distribution StatusIn Commercial Distribution
Brand NameIBEX 2-step LED slit lamp
Version Model Number2L
Company DUNS078605507
Company NameTrevi Technology, Inc.
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com
Phone614-754-7175
Emailinfo@ibexeye.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100869228000427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJOBiomicroscope, Slit-Lamp, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-01

Devices Manufactured by Trevi Technology, Inc.

00869228000472 - IBEX Keratometer 2019-08-09 IBEX Keratometer is used for measuring the curvature of the anterior surface of the cornea, particularly for assessing the exten
00869228000410 - IBEX 5-step LED slit lamp2018-07-06 IBEX Slit Lamps are specialized LED illuminated biomicroscope that provide a stereoscopic magnified view of the eye structures i
00869228000427 - IBEX 2-step LED slit lamp2018-07-06IBEX Slit Lamps are specialized LED illuminated biomicroscope that provide a stereoscopic magnified view of the eye structures in crystal clear detail, enabling anatomical diagnoses to be made for a variety of eye conditions.
00869228000427 - IBEX 2-step LED slit lamp2018-07-06 IBEX Slit Lamps are specialized LED illuminated biomicroscope that provide a stereoscopic magnified view of the eye structures i
00869228000434 - IBEX Wireless LED Binocular Indirect Ophthalmoscope 2018-07-06 IBEX Wireless LED Binocular Indirect Ophthalmoscope is a specialized microscope that provides stereoscopic, wide-angled, high re
00869228000441 - Applanation Tonometer2018-07-06 IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cor
00869228000458 - IBEX LCD digital acuity chart2018-03-29 The IBEX LCD Acuity Chart is a specialized remote controlled digital acuity system. It is designed to provide a comprehensive sy

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.