Identity
- Trade Name
- Clip-on Occluder FDA UDI
- Generic Name
- Spectacle lens occluder FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B091121280 FDA UDI
- FDA Product Code
- HPB FDA UDI
- GMDN Term
- Spectacle lens occluder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1410 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spectacle lens occluder
Clip-on Occluder by Gulden Ophthalmics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spectacle lens occluder.
- Clip-on Spielmann — Gulden Ophthalmics · Class I
- Opto Clip (2 pk) — Gulden Ophthalmics · Class I
- Clip-on Multiple Pinhole Occluder — Gulden Ophthalmics · 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
- Gulden Ophthalmics
Sources (1)
- FDA UDI d16ad753-172d-4cb6-91ab-80425bdcd5fd 32 fields · synced Jun 8, 2026