12mm Eye Sphere (non-sterile) 14151

GUDID B091141510

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

Gulden Ophthalmics Inc.

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• Primary Device ID: B091141510
• NIH Device Record Key: c6f8be8c-ef1e-488f-922b-bc27916b435b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 12mm Eye Sphere (non-sterile)
• Version Model Number: 14151
• Catalog Number: 14151
• 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: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B091141510 [Primary]

FDA Product Code

• HPZ: Implant, Eye Sphere

Sterilization

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

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

Hydrogen Peroxide;Ethylene Oxide

[B091141510]

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 [12mm Eye Sphere (non-sterile)]

• B091141511: Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable
• B091141510: Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable