12mm Sterile Orbital Implant (PMMA)

FDA UDI

Class II (US FDA UDI)

by Gulden Ophthalmics

Identity

Trade Name: 12mm Sterile Orbital Implant (PMMA) FDA UDI
Generic Name: Orbital sphere implant FDA UDI
Model / Reference: 14251 FDA UDI

Identifiers

Catalog Number: 14251 FDA UDI
Primary DI / UDI-DI: B091142510 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 — 12 Millimeter FDA UDI

Category: Orbital sphere implant

12mm 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Gulden Ophthalmics

Sources (1)

FDA UDI a0efcef3-b67c-4e32-ba9e-838597d95fde 35 fields · synced Jun 8, 2026