20mm Eye Sphere (non-sterile) 14155

GUDID B091141550

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.

Gulden Ophthalmics Inc.

Orbital sphere implant
Primary Device IDB091141550
NIH Device Record Key2427da49-8f8c-4028-b16e-fba02b7deaaf
Commercial Distribution StatusIn Commercial Distribution
Brand Name20mm Eye Sphere (non-sterile)
Version Model Number14155
Catalog Number14155
Company DUNS002373249
Company NameGulden Ophthalmics Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com
Phone1-800-659-2250
Emailadmin@guldenophthalmics.com

Device Dimensions

Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB091141550 [Primary]

FDA Product Code

HPZImplant, Eye Sphere

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-27
Device Publish Date2023-07-19

On-Brand Devices [20mm Eye Sphere (non-sterile)]

B091141551Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the futu
B091141550Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the futu

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