Identity
- Trade Name
- VersaCut Blade Set FDA UDI
- Generic Name
- Tissue morcellation system FDA UDI
- Device Name
- Additional DM DI:07290109143767 FDA UDI
- Model / Reference
- VersaCut Blade Set FDA UDI
- Description
- Additional DM DI:07290109143767 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109140605 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Tissue morcellation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Tissue morcellation system
VersaCut Blade Set by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system.
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- MultiCut Solo — Asclepion Laser Technologies GmbH · Class II
- MultiCut Blade 400 — Asclepion Laser Technologies GmbH · Class II
- BLUEENDO — TROKAMED GmbH · Class II
- BLUEENDO — TROKAMED GmbH · Class II
- TruClear — Covidien LP · Class II
- NICO Myriad — NICO Corporation · 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
- Lumenis
Sources (1)
- FDA UDI 5778c7fb-ebc7-40dc-8516-3dc85400f3e8 34 fields · synced May 30, 2026