Primary Device ID | B091141550 |
NIH Device Record Key | 2427da49-8f8c-4028-b16e-fba02b7deaaf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 20mm Eye Sphere (non-sterile) |
Version Model Number | 14155 |
Catalog Number | 14155 |
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 | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com | |
Phone | 1-800-659-2250 |
admin@guldenophthalmics.com |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Outer Diameter | 20 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B091141550 [Primary] |
HPZ | Implant, Eye Sphere |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
[B091141550]
Hydrogen Peroxide;Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-27 |
Device Publish Date | 2023-07-19 |
B091141551 | Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the futu |
B091141550 | Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the futu |