Bilateral Conformer 22 Regular

FDA UDI

Class II (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name: Bilateral Conformer 22 Regular FDA UDI
Generic Name: Ophthalmic conformer FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 19-094 FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 10697660001057 FDA UDI
FDA Product Code: HQN FDA UDI
GMDN Term: Ophthalmic conformer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.3130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 28 Millimeter FDA UDI
Width — 23 Nanometer FDA UDI
Depth — 1.8 Millimeter FDA UDI

Category: Ophthalmic conformer

Bilateral Conformer 22 Regular by Oculo-Plastik Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
Silicone Conformer — JARDON EYE PROSTHETICS, INC. · Class II
PROKERA® — BioTissue Holdings Inc. · Class II
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Oculo-Plastik Inc

Sources (1)

FDA UDI 3a63407d-8387-462b-b5b2-d0b843391e9c 35 fields · synced May 31, 2026