Identity
- Trade Name
- NICO Myriad SPECTRA FDA UDI
- Generic Name
- Tissue morcellation system control unit FDA UDI
- Device Name
- Myriad SPECTRA Console FDA UDI
- Model / Reference
- NN-7047 FDA UDI
- Description
- Myriad SPECTRA Console FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744027476 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
Yes
FDA UDI
Category: Tissue morcellation system control unit
NICO Myriad SPECTRA by NICO Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 034e4e26-95aa-4488-a6a3-1aff230f08e1 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026