| Primary Device ID | 00813125015350 |
| NIH Device Record Key | e777dff3-94ce-4c7f-a1de-cb3e4ff097cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G-Probe™ Illuminate Box of 6 |
| Version Model Number | 16000 |
| Company DUNS | 612920785 |
| Company Name | IRIDEX CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com | |
| Phone | (800)388-4747 |
| techsupport@iridex.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813125015350 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-03-24 |
| 00813125015718 | 16200 |
| 00813125015350 | 16000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() G-PROBE 87732831 5529525 Live/Registered |
IRIDEX Corporation 2017-12-22 |