Identity
- Trade Name
- Durette® III, regular FDA UDI
- Generic Name
- Epiocular radiation shield, reusable FDA UDI
- Device Name
- External laser shields, all-stainless-steel patient's goggles, regular, with 8 clear plastic attachments, 2 elastic headbands and a case. This stainless steel (surface treated) eye wear covers all wavelengths. USE ONLY WITH PURE LASERS OR PURE IPL SYSTEMS. DO NOT USE WITH SYSTEMS THAT ARE INTEGRATED WITH ELECTRIC CURRENT. FDA UDI
- Model / Reference
- 21-445 FDA UDI
- Description
- External laser shields, all-stainless-steel patient's goggles, regular, with 8 clear plastic attachments, 2 elastic headbands and a case. This stainless steel (surface treated) eye wear covers all wavelengths. USE ONLY WITH PURE LASERS OR PURE IPL SYSTEMS. DO NOT USE WITH SYSTEMS THAT ARE INTEGRATED WITH ELECTRIC CURRENT. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20697660002457 FDA UDI
- FDA Product Code
- IWS FDA UDI
- GMDN Term
- Epiocular radiation shield, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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: Epiocular radiation shield, reusable
Durette® III, regular by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Oculo-Plastik Inc
Sources (1)
- FDA UDI 8e916e94-18d2-484e-a224-0d5d35ae4315 34 fields · synced May 30, 2026