Identity
- Trade Name
- NICO Myriad-LX FDA UDI
- Generic Name
- General-purpose light source FDA UDI
- Device Name
- Replacement Bulb & Filters FDA UDI
- Model / Reference
- NN-9010 FDA UDI
- Description
- Replacement Bulb & Filters FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744026813 FDA UDI
- 510(k) Number
- K191599 FDA UDI
- FDA Product Code
- FSS FDA UDIFTD FDA UDI
- GMDN Term
- General-purpose light source FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose light source
NICO Myriad-LX by NICO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191599 also covers:
- Myriad-LX — NICO Corporation
- NICO Myriad — NICO Corporation
- NICO Myriad — NICO Corporation
- NICO Myriad — NICO Corporation
- NICO Myriad — NICO Corporation
- NICO Myriad — NICO Corporation
- NICO Myriad — NICO Corporation
- NICO Myriad NOVUS — NICO Corporation
- NICO Myriad-LX — NICO Corporation
- NICO Myriad-LX — NICO Corporation
- NICO Myriad-LX — NICO Corporation
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NICO Corporation
Sources (1)
- FDA UDI 0a4b0047-8f76-4788-9db3-8ab76477a1c4 35 fields · synced May 29, 2026