Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Orbital sphere implant FDA UDI
- Device Name
- Silicone eye sphere, 22.0mm diameter, packaged individually, non-sterile, disposable, box of 1 FDA UDI
- Model / Reference
- 4128E FDA UDI
- Description
- Silicone eye sphere, 22.0mm diameter, packaged individually, non-sterile, disposable, box of 1 FDA UDI
Identifiers
- Catalog Number
- 4128E FDA UDI
- Primary DI / UDI-DI
- 00190660036089 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orbital sphere implant
Ambler Surgical by Ambler Surgical, LLC — 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
- 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
- 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
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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 3910e476-8aba-421a-b186-32adb26f6480 35 fields · synced May 30, 2026