| Primary Device ID | B091141511 |
| NIH Device Record Key | 5e18b9a5-6ec5-4671-8c9f-e035ee037f02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 12mm Eye Sphere (non-sterile) |
| Version Model Number | 14151 |
| Catalog Number | 14151 |
| Company DUNS | 002373249 |
| Company Name | Gulden Ophthalmics Inc. |
| Device Count | 12 |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-659-2250 |
| admin@guldenophthalmics.com | |
| Phone | 1-800-659-2250 |
| admin@guldenophthalmics.com |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B091141510 [Unit of Use] |
| HIBCC | B091141511 [Primary] |
| HPZ | Implant, Eye Sphere |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B091141511]
Hydrogen Peroxide;Ethylene Oxide
[B091141511]
Hydrogen Peroxide;Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
| B091141511 | Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable |
| B091141510 | Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable |