Bilateral Conformer 18 Regular

GUDID 10697660001156

Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.

Oculo-Plastik Inc

Ophthalmic conformer

• Primary Device ID: 10697660001156
• NIH Device Record Key: 1015106a-d104-4109-9734-34d6484593f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bilateral Conformer 18 Regular
• Version Model Number: 19-114
• Company DUNS: 257382580
• Company Name: Oculo-Plastik Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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: 514-381-3292
• Email: sales@oculoplastik.com

Device Dimensions

• Depth: 1.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10697660001156 [Primary]
HIBCC	M872191140 [Previous]

FDA Product Code

• HQN: Conformer, Ophthalmic

Sterilization

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

[10697660001156]

Ethylene Oxide;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-29
• Device Publish Date: 2019-10-21

On-Brand Devices [Bilateral Conformer 18 Regular]

• 10697660001156: Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of t
• M872191140: Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of t