Identity
- Trade Name
- AMA Optics Occluder FDA UDI
- Generic Name
- Ocular occluder/Maddox rod FDA UDI
- Device Name
- A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate the passage of light (vision) to the eye(s) during an eyesight examination (e.g., diagnosis/measurement of heterophoria/heterotropia, myopia). The part of the device used to cover the eye(s) is typically spoon- or oval-shaped, and may be fully opaque or incorporate small holes and/or a Maddox lens(es) [i.e., coloured lens(es)]; the device also incorporates a handle and/or binocular frame. This is a reusable device. FDA UDI
- Model / Reference
- O-MAGNETIC FDA UDI
- Description
- A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate the passage of light (vision) to the eye(s) during an eyesight examination (e.g., diagnosis/measurement of heterophoria/heterotropia, myopia). The part of the device used to cover the eye(s) is typically spoon- or oval-shaped, and may be fully opaque or incorporate small holes and/or a Maddox lens(es) [i.e., coloured lens(es)]; the device also incorporates a handle and/or binocular frame. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- OCCLM FDA UDI
- Primary DI / UDI-DI
- G506OCCLM0 FDA UDI
- FDA Product Code
- HPC FDA UDI
- GMDN Term
- Ocular occluder/Maddox rod FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1405 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Ocular occluder/Maddox rod
AMA Optics Occluder by AMA Optics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ocular occluder/Maddox rod.
- GYRUS ACMI — Gyrus Acmi, Inc. · Class I
- AMA Optics Occluder — AMA Optics, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- AMA Optics, Inc.
Sources (1)
- FDA UDI 63adffc2-1673-4d1a-a0be-888b5143025f 34 fields · synced Jun 8, 2026