Identity
- Trade Name
- Bio-Eye® FDA UDI
- Generic Name
- Ophthalmic conformer FDA UDI
- Device Name
- Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations. FDA UDI
- Model / Reference
- I0016P FDA UDI
- Description
- Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854066006083 FDA UDI
- 510(k) Number
- K003338 FDA UDI
- FDA Product Code
- HQN FDA UDIMTZ FDA UDIHPZ FDA UDI
- GMDN Term
- Ophthalmic conformer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.3130 FDA UDI886.3320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 16 Millimeter FDA UDI
Category: Orbital sphere implantOphthalmic conformerOrbital sphere implant wrap, non-biological
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 wrap, non-biological.
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
Cleared under the same submission
K003338 also covers:
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC.
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC.
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC.
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC.
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC.
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC.
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC.
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 c922f097-6f8b-4f82-9985-f44c023b53f5 36 fields · synced May 30, 2026