10mm Eye Sphere (non-sterile) 14150

GUDID B091141500

Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.

Gulden Ophthalmics Inc.

Orbital sphere implant

• Primary Device ID: B091141500
• NIH Device Record Key: 1ccece34-53e6-4d58-8aff-5795ce09fa70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10mm Eye Sphere (non-sterile)
• Version Model Number: 14150
• Catalog Number: 14150
• 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

Customer Support Contacts

• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 215-659-2250
• Email: admin@guldenophthalmics.com

Device Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B091141500 [Primary]

FDA Product Code

• HPZ: Implant, Eye Sphere

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

[B091141500]

Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-27
• Device Publish Date: 2023-07-19

On-Brand Devices [10mm Eye Sphere (non-sterile)]

• B091141501: Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surger
• B091141500: Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surger