Bio-Eye®

FDA UDI

Class II (US FDA UDI)

by Integrated Orbital Implants, Inc.

Identity

Trade Name: Bio-Eye® FDA UDI
Generic Name: Ophthalmic conformer FDA UDI
Device Name: Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations. FDA UDI
Model / Reference: I00022S FDA UDI
Description: Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations. FDA UDI

Identifiers

Primary DI / UDI-DI: 00854066006038 FDA UDI
510(k) Number: K982562 FDA UDI
FDA Product Code: HQN FDA UDI
HPZ FDA UDI
GMDN Term: Ophthalmic conformer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.3130 FDA UDI
886.3320 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 22 Millimeter FDA UDI

Category: Orbital sphere implant Ophthalmic conformer

Bio-Eye® by Integrated Orbital Implants, Inc. — 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
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
20mm Eye Sphere (non-sterile) — Gulden Ophthalmics · 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
22mm Sterile Orbital Implant (PMMA) — Gulden Ophthalmics · Class II

Cleared under the same submission

K982562 also covers:

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: Integrated Orbital Implants, Inc.

Sources (1)

FDA UDI 8a0b1805-e77d-4e15-9fd7-dec4791b6e12 36 fields · synced Jun 1, 2026