18mm Eye Sphere (non-sterile) 14154

GUDID B091141540

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

Gulden Ophthalmics Inc.

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• Primary Device ID: B091141540
• NIH Device Record Key: 8c878998-22ee-4724-8486-d76892ca6cc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 18mm Eye Sphere (non-sterile)
• Version Model Number: 14154
• Catalog Number: 14154
• 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: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com

Device Dimensions

• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B091141540 [Primary]

FDA Product Code

• HPZ: Implant, Eye Sphere

Sterilization

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

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

Hydrogen Peroxide;Ethylene Oxide

[B091141540]

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 [18mm Eye Sphere (non-sterile)]

• B091141541: Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the futu
• B091141540: Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the futu