G-Probe™ Box of 6
GUDID 00851089000227
IRIDEX CORPORATION
Ophthalmic laser system beam guide| Primary Device ID | 00851089000227 |
| NIH Device Record Key | f742192b-22f5-4fa5-9300-4c3035b0c67e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G-Probe™ Box of 6 |
| Version Model Number | 11256 |
| 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 |
Customer Support Contacts
| Phone | (800) 388-4747 |
| techsupport@iridex.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851089000227 [Primary] |
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by IRIDEX CORPORATION
| 00813125010584 - OMA (810 nm) | 2024-05-14 OMA, 810nm, for Zeiss Visu 150/200 Operating Microscope |
| 00813125010591 - OMA (810 nm) | 2024-05-14 OMA, 810 nm, for Leica/Wild M650/M690 Operating Microscope |
| 00813125010645 - OMA (810 nm) | 2024-05-14 OMA, 810 nm, for OPMI-6 Operating Microscope |
| 00813125016975 - SLA EasyView™ (577 nm) | 2024-05-14 for Haag Streit 900 BM/BQ Slit Lamp |
| 00813125016999 - SLA (577 nm) | 2024-05-14 for Zeiss 30 slit lamp or equivalent |
| 00813125017019 - SLA (532 nm) | 2024-05-14 for Zeiss 30 CSO or equivalent |
| 00813125010935 - SLA (810 nm) | 2024-05-10 SLA, 810 nm, for Haag Streit w/MM Slit Lamp |
| 00813125011147 - SLA EasyFit™ (532 nm) | 2024-05-10 SLA EasyFit™, 532nm, for Zeiss 30 & Split-Mirror Slit Lamp |
Trademark Results [G-Probe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 G-PROBE 87732831 5529525 Live/Registered |
IRIDEX Corporation 2017-12-22 |
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