| Primary Device ID | 00862394000215 |
| NIH Device Record Key | 5e865e3e-c632-4057-9a3e-c1058222dcfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Boston Keratoprosthesis Snap-on TypeI |
| Version Model Number | SOF-T15P |
| Catalog Number | SOF-T15P |
| Company DUNS | 073825945 |
| Company Name | Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Phone | 617 573 4463 |
| larisa_gelfand@meei.harvard.edu |
| Outer Diameter | 5 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862394000215 [Primary] |
| HQM | Keratoprosthesis, Permanent Implant |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-30 |
| 00862394000253 | Boston Keratoprosthesis Snap-on TypeI 7.0 mm Titanium Back Plate. |
| 00862394000246 | Boston Keratoprosthesis Snap-on TypeI 8.5 mm Titanium Back Plate. |
| 00862394000239 | Boston Keratoprosthesis Snap-on TypeI 7mm PMMA Back Plate |
| 00862394000222 | Boston Keratoprosthesis, Snap-on TypeI. 8.5 mm PMMA Back Plate. |
| 00862394000215 | The Boston Keratoprosthesis ( KPro) Snap-on TypeI, PMMA Aphakia |
| 00862394000208 | The Boston Keratoprosthesis Snap-on TypeI Aphakia |