| Primary Device ID | 10632307002226 |
| NIH Device Record Key | 3b31bdc3-5583-42a2-b322-731894f31b20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DMEK Infusion Sleeve |
| Version Model Number | PD500.27 |
| Company DUNS | 622467348 |
| Company Name | PEREGRINE SURGICAL, LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00632307002229 [Primary] |
| GS1 | 10632307002226 [Package] Contains: 00632307002229 Package: Box [5 Units] In Commercial Distribution |
| KYG | Device, Irrigation, Ocular Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
[10632307002226]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2018-05-15 |
| 00632307002274 - 23GA Membrane Scraper | 2023-05-18 23GA Membrane Scraper |
| 00632307002281 - 25GA Membrane Scraper | 2023-05-18 25GA Membrane Scraper |
| 10632307002295 - 23GA Soft Tip Cannula - 1mm Silicone | 2023-05-18 23GA Soft Tip Cannula - 1mm Silicone |
| 10632307002301 - 25GA Soft Tip Cannula - 1mm Silicone | 2023-05-18 25GA Soft Tip Cannula - 1mm Silicone |
| 10632307002318 - 25GA Flexible 41GA Cannula | 2023-05-18 25GA Flexible 41GA Cannula |
| 00632307002144 - 60 Degree DMEK/DSAEK Forceps | 2020-08-24 60 Degree DMEK/DSAEK Forceps |
| 10632307001465 - 20GA Soft Tip Cannula | 2019-10-07 20GA Soft Tip Cannula |
| 10632307001472 - 20GA Flexible 41GA Cannula | 2019-10-07 20GA Flexible 41GA Cannula |