Identity
- Trade Name
- NICO Myriad FDA UDI
- Generic Name
- Tissue morcellation system handpiece, line-powered FDA UDI
- Device Name
- Handpiece 19 ga x 21.5 cm (Paedi) FDA UDI
- Model / Reference
- NN-8020 FDA UDI
- Description
- Handpiece 19 ga x 21.5 cm (Paedi) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816744028206 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Tissue morcellation system handpiece, line-powered 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
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
No
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: Tissue morcellation system handpiece, line-powered
NICO Myriad by NICO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- NICO Corporation
Sources (1)
- FDA UDI e0be4378-4395-426c-8721-9250f69c79b0 34 fields · synced Jun 8, 2026