| Primary Device ID | 00813125014506 |
| NIH Device Record Key | 4a544cb9-516b-4f61-ab93-2caf229292e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eye Safety Filter, Two-Position (577 nm) |
| Version Model Number | 65473 |
| 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 | |
| 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 | 00813125014506 [Primary] |
| HQF | Laser, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-30 |
| Device Publish Date | 2024-10-22 |
| 00813125014506 | For use on the Zeiss Dovetails OD3 @ 577 nm |
| 00813125014490 | For use on the Leica or Wild Dovetails OD3 @ 577 nm |