Primary Device ID | 00813125016487 |
NIH Device Record Key | fb1c8ce2-6ca0-42f4-bada-a5ef3cd84b0c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OcuLight GL Laser Console |
Version Model Number | 33004-1 |
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 | 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 | 00813125016487 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-02-24 |
Device Publish Date | 2022-02-16 |
00813125015381 - Iridex 577 Laser | 2024-01-26 The Iridex® 577 (577 nm, true-yellow) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-W |
00813125015473 - Iridex 532 Laser | 2024-01-26 The Iridex® 532 (532, green) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-Wave for e |
00813125015282 - TxCell for IQ577, Iridex Z 30 & CSO980 | 2022-08-09 TxCell Scanning Laser Delivery System for IQ577, Iridex Z 30 & CSO980 (without prism) |
00813125015305 - TxCell for IQ577, H/S 900BM/BQ & CSO9900 | 2022-08-09 TxCell Scanning Laser Delivery System for IQ577, H/S 900BM/BQ & CSO9900 |
00813125015312 - TxCell for IQ532, Iridex Z 30 & CSO9800 | 2022-08-09 TxCell Scanning Laser Delivery System for IQ532, Iridex Z30 & CSO9800 (without prism) |
00813125015336 - TxCell for IQ532, H/S 900BM/BQ & CSO9900 | 2022-08-09 TxCell Scanning Laser Delivery System for IQ532, H/S 900BM/BQ & CSO9900 |
00813125015459 - IQ532XP Laser Console | 2022-02-24 |
00813125016487 - OcuLight GL Laser Console | 2022-02-24 |
00813125016487 - OcuLight GL Laser Console | 2022-02-24 |