Identity
- Trade Name
- TruClear FDA UDI
- Generic Name
- Tissue morcellation system FDA UDI
- Device Name
- Dense Tissue Shaver Mini FDA UDI
- Model / Reference
- 72204064 FDA UDI
- Description
- Dense Tissue Shaver Mini FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521744097 FDA UDI
- 510(k) Number
- K161763 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Tissue morcellation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 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
Yes
FDA UDI
Category: Tissue morcellation system
TruClear by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system.
- SUPERCUT — Karl Storz GmbH & Co. KG · Class II
- VersaCut Sterile Outer Blade — Lumenis · Class II
- MultiCut Solo — Asclepion Laser Technologies GmbH · Class II
- MultiCut Blade 400 — Asclepion Laser Technologies GmbH · Class II
- BLUEENDO — TROKAMED GmbH · Class II
- Versacut Tissue Morcellator — Lumenis · Class II
- BLUEENDO — TROKAMED GmbH · Class II
- Versacut™ — Lumenis · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 2340375f-c519-4901-b637-7f2c628c39c2 35 fields · synced Jun 8, 2026