Bilateral Conformer 22 Small With Holes

GUDID M87219092T01

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 Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer Ophthalmic conformer

Primary Device ID	M87219092T01
NIH Device Record Key	5be9aa3c-6029-4388-a17e-9bfbae2b13d3
Commercial Distribution Discontinuation	2022-03-24
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Bilateral Conformer 22 Small With Holes
Version Model Number	19-092T
Company DUNS	257382580
Company Name	Oculo-Plastik 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	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com

Device Dimensions

Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter
Depth	1.8 Millimeter
Width	21 Millimeter
Length	25.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M87219092T01 [Primary]

FDA Product Code

HQN	Conformer, Ophthalmic