Primary Device ID | 00813125014599 |
NIH Device Record Key | 2fe0e3d8-b5b2-4542-bf91-aa8dc7c1176a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FlexFiber™ 600, Single |
Version Model Number | 15706-1 |
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 | |
Phone | (800) 388-4747 |
techsupport@iridex.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813125014599 [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 |
00813125016920 - LIO Plus (810 nm) | 2024-04-04 |
00813125016937 - LIO Plus Large Spot (810 nm) | 2024-04-04 |
00813125016944 - LIO Plus (532 nm) | 2024-04-04 |
00813125016951 - LIO Plus (532 nm & 810 nm) | 2024-04-04 |
00813125016968 - LIO Plus (577 nm) | 2024-04-04 |
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) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FLEXFIBER 90738360 not registered Live/Pending |
Viavi Solutions Inc. 2021-05-27 |
FLEXFIBER 90372594 not registered Live/Pending |
CLOTHPROMOTIONS PLUS, INC. 2020-12-10 |
FLEXFIBER 87849797 not registered Dead/Abandoned |
CLOTHPROMOTIONS PLUS, INC. 2018-03-26 |
FLEXFIBER 87284154 not registered Dead/Abandoned |
Clothpromotions Plus, Inc 2016-12-29 |