Medium Conformer with Holes (non-sterile)

FDA UDI

Class II (US FDA UDI)

by Gulden Ophthalmics

Identity

Trade Name: Medium Conformer with Holes (non-sterile) FDA UDI
Generic Name: Ophthalmic conformer FDA UDI
Device Name: Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it. The holes in the conformer provide ventilation and act as an access point for eye drops. FDA UDI
Model / Reference: 14168 FDA UDI
Description: Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it. The holes in the conformer provide ventilation and act as an access point for eye drops. FDA UDI

Identifiers

Catalog Number: 14168 FDA UDI
Primary DI / UDI-DI: B091141681 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

Dimensions & Sizes

Size: Width — 0.94 Inch FDA UDI
Length — 0.83 Inch FDA UDI

Category: Ophthalmic conformer

Medium Conformer with Holes (non-sterile) by Gulden Ophthalmics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic conformer.

Bilateral Conformer 22 Small — Oculo-Plastik Inc · Class II
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
SILICONE CONFORMER (FLEXIBLE) — FCI S A S FCI 20 22 · Class II
Ambler Surgical — Ambler Surgical, LLC · Class II
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: Gulden Ophthalmics

Sources (1)

FDA UDI 0ac77209-2cc1-4032-88c8-3642b5de433d 36 fields · synced Jun 8, 2026