Identity
- Trade Name
- Silicone Eye Sphere - 18mm FDA UDI
- Generic Name
- Orbital sphere implant FDA UDI
- Device Name
- Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis. FDA UDI
- Model / Reference
- 14354 FDA UDI
- Description
- Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis. FDA UDI
Identifiers
- Catalog Number
- 14354 FDA UDI
- Primary DI / UDI-DI
- B091143540 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 18 Millimeter FDA UDI
Silicone Eye Sphere - 18mm by Gulden Ophthalmics — 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
- Gulden Ophthalmics
Sources (1)
- FDA UDI e79e061b-9e85-4e35-bdf7-6393bd0f5d2f 37 fields · synced Jun 8, 2026