Pediatric Conformers

GUDID 20697660001009

4 different models. 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 Ophthalmic conformer

Primary Device ID	20697660001009
NIH Device Record Key	ff18dc8c-a849-4e65-b42c-ff9b97bd0a94
Commercial Distribution Status	In Commercial Distribution
Brand Name	Pediatric Conformers
Version Model Number	19-091
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	true
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
Phone	514-381-3292
Email	sales@oculoplastik.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20697660001009 [Primary]
HIBCC	M872190911 [Previous]

FDA Product Code

HQN	Conformer, Ophthalmic