| Primary Device ID | 00813125016647 |
| NIH Device Record Key | d1d5f496-5402-4d25-bad7-85d16b36e8e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MicroPulse P3 Device Single |
| Version Model Number | 15522-1 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813125016647 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-18 |
| Device Publish Date | 2019-03-08 |
| 00813125010584 - OMA (810 nm) | 2024-05-14 OMA, 810nm, for Zeiss Visu 150/200 Operating Microscope |
| 00813125010591 - OMA (810 nm) | 2024-05-14 OMA, 810 nm, for Leica/Wild M650/M690 Operating Microscope |
| 00813125010645 - OMA (810 nm) | 2024-05-14 OMA, 810 nm, for OPMI-6 Operating Microscope |
| 00813125016975 - SLA EasyView™ (577 nm) | 2024-05-14 for Haag Streit 900 BM/BQ Slit Lamp |
| 00813125016999 - SLA (577 nm) | 2024-05-14 for Zeiss 30 slit lamp or equivalent |
| 00813125017019 - SLA (532 nm) | 2024-05-14 for Zeiss 30 CSO or equivalent |
| 00813125010935 - SLA (810 nm) | 2024-05-10 SLA, 810 nm, for Haag Streit w/MM Slit Lamp |
| 00813125011147 - SLA EasyFit™ (532 nm) | 2024-05-10 SLA EasyFit™, 532nm, for Zeiss 30 & Split-Mirror Slit Lamp |