Durette #4, PMMA (20 mm, 3.5 cc)

FDA UDI

Class II (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name: Durette #4, PMMA (20 mm, 3.5 cc) FDA UDI
Generic Name: Orbital sphere implant FDA UDI
Device Name: The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses. FDA UDI
Model / Reference: 12-420 FDA UDI
Description: The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses. FDA UDI

Identifiers

Primary DI / UDI-DI: 10697660000418 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 20 Millimeter FDA UDI
Total Volume — 3.5 Milliliter FDA UDI

Durette #4, PMMA (20 mm, 3.5 cc) by Oculo-Plastik Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 09cb71f0-8ed2-4b4a-b5c5-4487be3b46e4 36 fields · synced May 30, 2026