Primary Device ID | 00813125016319 |
NIH Device Record Key | 5d18ec0a-83fa-48d2-a335-921574738128 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SLx Laser Console |
Version Model Number | 13030-220 |
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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
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 | |
Phone | (800) 388-4747 |
techsupport@iridex.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813125016319 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
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 |