Identity
- Trade Name
- Morcellator FDA UDI
- Generic Name
- Tissue morcellation system handpiece set FDA UDI
- Device Name
- Gear unit Morcellator FDA UDI
- Model / Reference
- 5163NOU FDA UDI
- Description
- Gear unit Morcellator FDA UDI
Identifiers
- Primary DI / UDI-DI
- ENOU5163NOU0 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Tissue morcellation system handpiece set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 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
Moist Heat or Steam Sterilization FDA UDI
Category: Tissue morcellation system handpiece set
Morcellator by Nouvag AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system handpiece set.
- Trocar sleeve 12mm — Nouvag AG · Class II
- Protective tube 12mm — Nouvag AG · Class II
- Protective tube 15mm — Nouvag AG · Class II
- Cutting tube 20mm — Nouvag AG · Class II
- Trocar sleeve 15mm — Nouvag AG · Class II
- Obturator 20mm — Nouvag AG · Class II
- Protective tube 20mm — Nouvag AG · Class II
- Obturator 12mm — Nouvag AG · Class II
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
- Nouvag AG
Sources (1)
- FDA UDI cb25163e-1932-46ba-9b20-7a0406e31682 34 fields · synced Jun 8, 2026