| Primary Device ID | 00813125015305 |
| NIH Device Record Key | 5d2f4627-5e8f-4a02-aabc-384e5a5d2cd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TxCell for IQ577, H/S 900BM/BQ & CSO9900 |
| Version Model Number | 70295 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813125015305 [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 | 2022-08-09 |
| Device Publish Date | 2022-08-01 |
| 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 |