Identity
- Trade Name
- NICO Myriad FDA UDI
- Generic Name
- Open surgical site internal light FDA UDI
- Device Name
- Illumination Pack - 11 Gauge FDA UDI
- Model / Reference
- NN-1000 FDA UDI
- Description
- Illumination Pack - 11 Gauge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744020101 FDA UDI
- 510(k) Number
- K191599 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Open surgical site internal light 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Open surgical site internal light
NICO Myriad by NICO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Open surgical site internal light.
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- Sunoptic Technologies — Sunoptic Technologies · Class II
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- EMSRUN — Wuxi Emsrun Technology Co., Ltd. · Class I
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 NOVUS — NICO Corporation
- NICO Myriad-LX — 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 |
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Manufacturer
- Manufacturer
- NICO Corporation
Sources (1)
- FDA UDI 40c502e5-8a1d-4079-a5f7-6861770a06d4 35 fields · synced May 29, 2026