Identity
- Trade Name
- TCM 3000 BL Morcellator FDA UDI
- Generic Name
- Line-powered surgical power tool system motor FDA UDI
- Device Name
- Control unit for Morcellator FDA UDI
- Model / Reference
- 3281 FDA UDI
- Description
- Control unit for Morcellator FDA UDI
Identifiers
- Primary DI / UDI-DI
- ENOU32810 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Line-powered surgical power tool system motor 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: Line-powered surgical power tool system motor
TCM 3000 BL Morcellator by Nouvag AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Line-powered surgical power tool system motor.
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- DYONICS — Smith & Nephew, Inc. · Class I
- D'Liv Tip — Jeisys Medical Inc. · Class I
- D'Liv Tip — Jeisys Medical Incorporated · Class I
- D'Liv Main Body — Jeisys Medical Inc. · Class I
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 5e5b047e-358f-43f7-8e9d-598d3ff3ffbb 34 fields · synced May 31, 2026