Identity
- Trade Name
- McLaren FDA UDI
- Generic Name
- Tinted non-prescription spectacles FDA UDI
- Device Name
- SUNGLASSES- MLMS-85S04 C02 GUN ORAN/BLK 128-0 145F FDA UDI
- Model / Reference
- MLMS-85S0402 FDA UDI
- Description
- SUNGLASSES- MLMS-85S04 C02 GUN ORAN/BLK 128-0 145F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00730638423277 FDA UDI
- FDA Product Code
- HQY FDA UDI
- GMDN Term
- Tinted non-prescription spectacles FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5850 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
Yes
FDA UDI
Over-the-Counter
Yes
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: Tinted non-prescription spectacles
McLaren by L'Amy, Incorporated — 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
- L'Amy, Incorporated
Sources (1)
- FDA UDI 7babc56e-1a3b-44ac-ac78-26c65ad3e466 35 fields · synced May 31, 2026