Identity
- Trade Name
- NICO Myriad NOVUS FDA UDI
- Generic Name
- Tissue morcellation system control unit FDA UDI
- Device Name
- LOANER Console FDA UDI
- Model / Reference
- NN-7012L FDA UDI
- Description
- LOANER Console FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744026929 FDA UDI
- 510(k) Number
- K191599 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Tissue morcellation system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Category: Tissue morcellation system control unit
NICO Myriad NOVUS by NICO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system control unit.
- Aveta Disposable Resecting Handset — Meditrina, Inc. · Class II
- VersaCut™ — Lumenis · Class II
- EndoRotor® EndoSurgery System - Console — INTERSCOPE, INC · Class II
- TRUCLEARTM Control Unit — Smith & Nephew, Inc. · Class II
- TRUCLEARTM Control Unit — Smith & Nephew, Inc. · Class II
- TRUCLEARTM Control Unit — Smith & Nephew, Inc. · Class II
- Aveta Disposable Resecting Handset — Meditrina, Inc. · Class II
- MyoSure Tissue Removal System Control Unit — Hologic, Inc. · Class II
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-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 538e19f8-3204-4519-8bc7-10542a5229e6 35 fields · synced May 30, 2026