Primary Device ID | 00813125016524 |
NIH Device Record Key | 15ac08f2-72df-433d-9a5f-921879877726 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SLA EasyView™ (532 nm) |
Version Model Number | 65504 |
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 | |
Phone | (800) 388-4747 |
techsupport@iridex.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813125016524 [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 | 2024-05-10 |
Device Publish Date | 2024-05-02 |
00813125010249 - Eye Safety Filter, Fixed (532 nm) | 2024-10-30 For use on the Moeller-Wedel Dovetails OD3 @ 532 nm |
00813125010256 - Eye Safety Filter, Fixed (532 nm) | 2024-10-30 For use on the Leica M841 Dovetails OD3 @ 532 nm |
00813125010263 - Eye Safety Filter, Two-Position (532 nm) | 2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 532 nm |
00813125010270 - Eye Safety Filter, Two-Position (532 nm) | 2024-10-30 For use on the Zeiss Dovetails OD3 @ 532 nm |
00813125014490 - Eye Safety Filter, Two-Position (577 nm) | 2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 577 nm |
00813125014506 - Eye Safety Filter, Two-Position (577 nm) | 2024-10-30 For use on the Zeiss Dovetails OD3 @ 577 nm |
00813125014513 - Eye Safety Filter, Two-Position (532 nm) | 2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 532 nm |
00813125014520 - Eye Safety Filter, Two-Position (532 nm) | 2024-10-30 For use on the Zeiss Dovetails OD3 @ 532 nm |