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
Primary Device IDM87219092T01
NIH Device Record Key5be9aa3c-6029-4388-a17e-9bfbae2b13d3
Commercial Distribution Discontinuation2022-03-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBilateral Conformer 22 Small With Holes
Version Model Number19-092T
Company DUNS257382580
Company NameOculo-Plastik Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com

Device Dimensions

Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter
Depth1.8 Millimeter
Width21 Millimeter
Length25.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM87219092T01 [Primary]

FDA Product Code

HQNConformer, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

[M87219092T01]

Ethylene Oxide;Hydrogen Peroxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-03-25
Device Publish Date2016-10-16

On-Brand Devices [Bilateral Conformer 22 Small With Holes]

10697660001026Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of t
M87219092T01Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of t
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