Identity
- Trade Name
- TruClear FDA UDI
- Generic Name
- Tissue morcellation system FDA UDI
- Device Name
- Control Unit FDA UDI
- Model / Reference
- 7209808 FDA UDI
- Description
- Control Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521749931 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
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
TruClear by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tissue morcellation system.
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- BLUEENDO — TROKAMED GmbH · Class II
- Versacut Tissue Morcellator — Lumenis · Class II
- BLUEENDO — TROKAMED GmbH · Class II
- Versacut™ — Lumenis · Class II
Cleared under the same submission
K031787 also covers:
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 04f7e02c-f5ef-4e5c-8b53-62d98c9b6a42 36 fields · synced Jun 7, 2026