| Primary Device ID | B091142520 |
| NIH Device Record Key | c4224801-01ed-499c-9de8-d8d4d1415552 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 14mm Sterile Orbital Implant (PMMA) |
| Version Model Number | 14252 |
| Catalog Number | 14252 |
| Company DUNS | 002373249 |
| Company Name | Gulden Ophthalmics Inc. |
| 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 | 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 | 18006592250 |
| admin@guldenophthalmics.com | |
| Phone | 18006592250 |
| admin@guldenophthalmics.com |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B091142520 [Primary] |
| HPZ | Implant, Eye Sphere |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-01-29 |
| B091141500 - 10mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a pros |
| B091141510 - 12mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis. |
| B091141520 - 14mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis. |
| B091141530 - 16mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis. |
| B091141540 - 18mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis. |
| B091141550 - 20mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis. |
| B091141560 - 22mm Eye Sphere (non-sterile) | 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis. |
| B091112000 - Tangent Screen | 2023-07-13 |