| Primary Device ID | 00869228000472 |
| NIH Device Record Key | 044a31e8-d075-44f1-a31e-a1a22ac72451 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IBEX Keratometer |
| Version Model Number | MK |
| Company DUNS | 078605507 |
| Company Name | Trevi Technology, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 614-754-7175 |
| info@ibexeye.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869228000472 [Primary] |
| HLQ | Keratoscope, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2018-01-01 |
| 00869228000472 - IBEX Keratometer | 2019-08-09IBEX Keratometer is used for measuring the curvature of the anterior surface of the cornea, particularly for assessing the extent and axis of astigmatism. |
| 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 lamp | 2018-07-06 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 lamp | 2018-07-06 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 Tonometer | 2018-07-06 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 chart | 2018-03-29 The IBEX LCD Acuity Chart is a specialized remote controlled digital acuity system. It is designed to provide a comprehensive sy |