Silicone Spheres (16 mm, 2.1 cc)

FDA UDI

Class II (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name: Silicone Spheres (16 mm, 2.1 cc) FDA UDI
Generic Name: Orbital sphere implant FDA UDI
Device Name: Silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery. FDA UDI
Model / Reference: 11-216 FDA UDI
Description: Silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery. FDA UDI

Identifiers

Primary DI / UDI-DI: 10697660000197 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

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Serial Number

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Expiration Date

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Manufacturing Date

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MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Total Volume — 2.1 Milliliter FDA UDI
Outer Diameter — 16 Millimeter FDA UDI

Silicone Spheres (16 mm, 2.1 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 fd2682c5-281c-4aed-8d04-5a77b2ecfe99 36 fields · synced Jun 6, 2026