Silicone Eye Sphere - 16mm 14353

GUDID B091143530

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

Gulden Ophthalmics Inc.

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• Primary Device ID: B091143530
• NIH Device Record Key: 079657b5-1076-4ac4-94c7-52f7f861d06e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Eye Sphere - 16mm
• Version Model Number: 14353
• Catalog Number: 14353
• 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
• 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: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B091143530 [Primary]

FDA Product Code

• HPZ: Implant, Eye Sphere

Sterilization

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

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

[B091143530]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

Devices Manufactured by Gulden Ophthalmics Inc.

• B091141500 - 10mm Eye Sphere (non-sterile): 2023-07-27 Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a pros
• B091141510 - 12mm Eye Sphere (non-sterile): 2023-07-27 Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
• B091141520 - 14mm Eye Sphere (non-sterile): 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
• B091141530 - 16mm Eye Sphere (non-sterile): 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
• B091141540 - 18mm Eye Sphere (non-sterile): 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
• B091141550 - 20mm Eye Sphere (non-sterile): 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
• B091141560 - 22mm Eye Sphere (non-sterile): 2023-07-27 Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
• B091112000 - Tangent Screen: 2023-07-13