Primary Device ID | B091143460 |
NIH Device Record Key | aa9d553d-1309-450a-8811-b847785a4b3a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Symblepharon Ring - 22mm |
Version Model Number | 14346 |
Catalog Number | 14346 |
Company DUNS | 002373249 |
Company Name | Gulden Ophthalmics Inc. |
Device Count | 1 |
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 | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2200 |
admin@guldenophthalmics.com |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Outer Diameter | 22 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B091143460 [Primary] |
HQN | Conformer, Ophthalmic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
Hydrogen Peroxide;Ethylene Oxide
[B091143460]
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 |
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. |