Face Fixation Sticks (3pk)

GUDID B091153150

Gulden Ophthalmics Inc.

Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder Ophthalmic examination target holder

• Primary Device ID: B091153150
• NIH Device Record Key: edbf588b-ed61-4e1c-a10f-612d53e2ffa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Face Fixation Sticks (3pk)
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	B091153150 [Primary]

FDA Product Code

• HPL: Device, Fixation, Ac-Powered, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-13
• Device Publish Date: 2023-07-05

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