| Primary Device ID | 10632307001939 |
| NIH Device Record Key | 4804b112-6f22-474b-a746-f92125d98867 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 25GA Illuminating Laser Probe, SMA905 |
| Version Model Number | GA-0040079 |
| Company DUNS | 622467348 |
| Company Name | PEREGRINE SURGICAL, LTD. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(215)348-0456 |
| jayne@peregrine-surgical.com | |
| Phone | +1(215)348-0456 |
| jayne@peregrine-surgical.com |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Needle Gauge | 25 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00632307001932 [Primary] |
| GS1 | 10632307001939 [Package] Contains: 00632307001932 Package: Box [10 Units] In Commercial Distribution |
| HQF | Laser, ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10632307001939]
Ethylene Oxide
[10632307001939]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-01 |
| 10632307002127 | 25GA Illuminating Laser Probe, SMA905 |
| 10632307001939 | 25GA Illuminating Laser Probe, SMA905 |