| Primary Device ID | 00086239500214 |
| NIH Device Record Key | 267c034c-003c-477e-b066-a4fdb454dd71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Boston Keratoprosthesis Lucia type I with anodized back plate |
| Version Model Number | L-T1A |
| Catalog Number | L-T1A |
| 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 |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00086239500214 [Primary] |
| HQM | Keratoprosthesis, Permanent Implant |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
[00086239500214]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-23 |
| Device Publish Date | 2021-08-13 |
| 00862395000214 - Boston Keratoprosthesis Lucia Type I | 2021-10-12 Boston Keratoprosthesis Lucia Type 1 Aphakia with anodized Titanium back plate 7.8 mm BR (Brown ); BL (Blue) |
| 00086239500214 - Boston Keratoprosthesis Lucia type I with anodized back plate | 2021-08-23Boston Keratoprosthesis Type I Lucia with anodized back plate 7.8 mm Brown ( BR); Blue ( BL). |
| 00086239500214 - Boston Keratoprosthesis Lucia type I with anodized back plate | 2021-08-23 Boston Keratoprosthesis Type I Lucia with anodized back plate 7.8 mm Brown ( BR); Blue ( BL). |
| 00862394000208 - Boston Keratoprosthesis Snap-on TypeI | 2018-07-06 The Boston Keratoprosthesis Snap-on TypeI Aphakia |
| 00862394000215 - Boston Keratoprosthesis Snap-on TypeI | 2018-07-06 The Boston Keratoprosthesis ( KPro) Snap-on TypeI, PMMA Aphakia |
| 00862394000222 - Boston Keratoprosthesis Snap-on TypeI | 2018-07-06 Boston Keratoprosthesis, Snap-on TypeI. 8.5 mm PMMA Back Plate. |
| 00862394000239 - Boston Keratoprosthesis Snap-on TypeI | 2018-07-06 Boston Keratoprosthesis Snap-on TypeI 7mm PMMA Back Plate |
| 00862394000246 - Boston Keratoprosthesis Snap-on TypeI | 2018-07-06 Boston Keratoprosthesis Snap-on TypeI 8.5 mm Titanium Back Plate. |
| 00862394000253 - Boston Keratoprosthesis Snap-on TypeI | 2018-07-06 Boston Keratoprosthesis Snap-on TypeI 7.0 mm Titanium Back Plate. |