Identity
- Trade Name
- Colors in Optics FDA UDI
- Generic Name
- Magnifying spectacles FDA UDI
- Device Name
- Readers FDA UDI
- Model / Reference
- COLORS CXB109 - BL (+1.50) FDA UDI
- Description
- Readers FDA UDI
Identifiers
- Catalog Number
- CXB109 - BL (+1.50) FDA UDI
- Primary DI / UDI-DI
- 00781268813754 FDA UDI
- FDA Product Code
- HOI FDA UDI
- GMDN Term
- Magnifying spectacles FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5840 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
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: Magnifying spectacles
Colors in Optics CXB109 - BL (+1.50) is a premier spectacle frame designed for individuals who require enlarged text and images for optimal visual clarity, particularly for those with visual impairments. Our innovative design features convex lenses crafted from high-quality plastic or glass materials within a durable metal frame, ensuring a comfortable and secure fit.
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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
- Colors In Optics Ltd.
Sources (1)
- FDA UDI 810f23d7-44dd-4b4c-91a1-c895601cbb1d 35 fields · synced Jul 24, 2026