Identity
- Trade Name
- Orbital sphere implant FDA UDI
- Generic Name
- Orbital sphere implant FDA UDI
- Device Name
- An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone. FDA UDI
- Model / Reference
- ENUCLEATION EVISCERATION IMPLANT Ø 17 MM FDA UDI
- Description
- An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone. FDA UDI
Identifiers
- Catalog Number
- S6.1017U FDA UDI
- Primary DI / UDI-DI
- 03760087122480 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 17 Millimeter FDA UDI
Category: Orbital sphere implant
Orbital sphere implant by Fci S A S Fci 20 22 — 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
- 20mm Eye Sphere (non-sterile) — Gulden Ophthalmics · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- 22mm Sterile Orbital Implant (PMMA) — Gulden Ophthalmics · Class II
- 18mm Eye Sphere (non-sterile) — Gulden Ophthalmics · Class II
- EYE SPHERE PLASTIC 12MM DIAMETER — Katena Products, Inc. · Class II
- EYE SPHERE PLASTIC 22MM 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 |
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Manufacturer
- Manufacturer
- Fci S A S Fci 20 22
Sources (1)
- FDA UDI 8384608b-48b4-45bd-9cfb-45d30a20dad2 36 fields · synced Jun 8, 2026