Medium Conformer with Holes (non-sterile) 14168

GUDID B091141681

Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. Th

Gulden Ophthalmics Inc.

Ophthalmic conformer

• Primary Device ID: B091141681
• NIH Device Record Key: 0ac77209-2cc1-4032-88c8-3642b5de433d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medium Conformer with Holes (non-sterile)
• Version Model Number: 14168
• Catalog Number: 14168
• Company DUNS: 002373249
• Company Name: Gulden Ophthalmics Inc.
• Device Count: 100
• 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

Device Dimensions

• Width: 0.94 Inch
• Length: 0.83 Inch
• Width: 0.94 Inch
• Length: 0.83 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B091141680 [Unit of Use]
HIBCC	B091141681 [Primary]

FDA Product Code

• HQN: Conformer, Ophthalmic

Sterilization

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

[B091141681]

Hydrogen Peroxide;Ethylene Oxide

[B091141681]

Hydrogen Peroxide;Ethylene Oxide

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.

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• 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.