Small Sterile Eye Conformer (PMMA)

FDA UDI

Class II (US FDA UDI)

by Gulden Ophthalmics

Identity

Trade Name: Small Sterile Eye Conformer (PMMA) FDA UDI
Generic Name: Ophthalmic conformer FDA UDI
Model / Reference: 14264 FDA UDI

Identifiers

Catalog Number: 14264 FDA UDI
Primary DI / UDI-DI: B091142640 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

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 0.22 Inch FDA UDI
Length — 0.87 Inch FDA UDI
Width — 0.75 Inch FDA UDI

Category: Ophthalmic conformer

Small Sterile Eye Conformer (PMMA) by Gulden Ophthalmics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 34a84b5e-e1eb-480f-bcf5-512fa92b7639 35 fields · synced Jun 8, 2026