| Primary Device ID | B091142690 |
| NIH Device Record Key | 0090f2da-f0f2-45ff-a23f-789d0650d215 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Large Sterile Eye Conformer with Holes (PMMA) |
| Version Model Number | 14269 |
| Catalog Number | 14269 |
| 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 |
| Device Size Text, specify | 0 |
| Height | 0.26 Inch |
| Length | 0.98 Inch |
| Width | 0.87 Inch |
| Device Size Text, specify | 0 |
| Height | 0.26 Inch |
| Length | 0.98 Inch |
| Width | 0.87 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B091142690 [Primary] |
| HQN | Conformer, Ophthalmic |
| 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 |
| B091230120 - Silicone Suction Cup (10pk) | 2024-09-12 |
| 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. |