Identity
- Trade Name
- MultiCut Solo FDA UDI
- Generic Name
- Tissue morcellation system FDA UDI
- Model / Reference
- J19-3000-000 FDA UDI
Identifiers
- Catalog Number
- J19-3000-000 FDA UDI
- Primary DI / UDI-DI
- 04058784001115 FDA UDI
- 510(k) Number
- K213597 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
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
MultiCut Solo by Asclepion Laser Technologies GmbH — 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
- TruClear — Covidien LP · 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
- Asclepion Laser Technologies GmbH
Sources (1)
- FDA UDI 809698c3-f10f-4260-9767-7c7b807f6298 35 fields · synced May 30, 2026