Dix Magnetic Foreign Body Remover

GUDID B091161090

Gulden Ophthalmics Inc.

Eye spud Eye spud Eye spud

• Primary Device ID: B091161090
• NIH Device Record Key: 142ebb69-93c3-4ade-a873-40be4b0e3dd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dix Magnetic Foreign Body Remover
• Version Model Number: 1
• 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: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B091161090 [Primary]

FDA Product Code

• HNA: Spud, Ophthalmic

Sterilization

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

[B091161090]

Hydrogen Peroxide

[B091161090]

Hydrogen Peroxide

[B091161090]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-06
• Device Publish Date: 2022-11-28

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