20mm Sterile Orbital Implant (PMMA)

FDA UDI

Class II (US FDA UDI)

by Gulden Ophthalmics

Identity

Trade Name: 20mm Sterile Orbital Implant (PMMA) FDA UDI
Generic Name: Orbital sphere implant FDA UDI
Model / Reference: 14255 FDA UDI

Identifiers

Catalog Number: 14255 FDA UDI
Primary DI / UDI-DI: B091142550 FDA UDI
FDA Product Code: HPZ FDA UDI
GMDN Term: Orbital sphere implant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.3320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Outer Diameter — 20 Millimeter FDA UDI

Category: Orbital sphere implant

20mm Sterile Orbital Implant (PMMA) by Gulden Ophthalmics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orbital sphere implant.

MEDPOR — Stryker Leibinger · Class II
Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
Orbital sphere implant — FCI S A S FCI 20 22 · Class II
EZYPOR® Ø 20 mm — FCI S A S FCI 20 22 · Class II
Ambler Surgical — Ambler Surgical, LLC · Class II
EZYPOR® Ø 16 mm — FCI S A S FCI 20 22 · Class II
Orbital sphere implant — FCI S A S FCI 20 22 · Class II
EYE SPHERE PLASTIC 12MM DIAMETER — Katena Products, Inc. · Class II

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 9a272543-ddf8-40cc-a205-6a4d63c12a16 35 fields · synced Jun 8, 2026