Identity
- Trade Name
- EYEWEAR BY ROI OLEANDER SOFT BURGUNDY FDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Device Name
- 49-16-130 SOFT BURGUNDY KAREN KANE PETITES FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 49-16-130 SOFT BURGUNDY KAREN KANE PETITES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07484743151060 FDA UDI
- FDA Product Code
- HQZ FDA UDI
- GMDN Term
- Spectacle frame FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5842 FDA UDI
- Commercial Distribution
- Not 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
Eyewear By Roi Oleander Soft Burgundy by Eyewear By Roi, Limited — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Eyewear By Roi, Limited
Sources (1)
- FDA UDI 38fa9866-a702-45be-a1bf-292f8d1285dc 35 fields · synced May 31, 2026