Primary Device ID | 00851089000234 |
NIH Device Record Key | f116a393-d50d-4dae-9d4f-a53f2776fc1d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | G-Probe™ Single |
Version Model Number | 11256-1 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851089000234 [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 | 2016-09-24 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
G-PROBE 87732831 5529525 Live/Registered |
IRIDEX Corporation 2017-12-22 |