Identity
- Trade Name
- BLUEENDO FDA UDI
- Generic Name
- Tissue morcellation system FDA UDI
- Device Name
- Cutting module Ø 20 mm short for Morcellator System Release 2, Color Code yellow, single-use, sterile, 5 pcs./ box FDA UDI
- Model / Reference
- 53-001020 FDA UDI
- Description
- Cutting module Ø 20 mm short for Morcellator System Release 2, Color Code yellow, single-use, sterile, 5 pcs./ box FDA UDI
Identifiers
- Catalog Number
- 501-020-131 FDA UDI
- Primary DI / UDI-DI
- 04251303811893 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Tissue morcellation system 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
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
Blueendo by TROKAMED GmbH — 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
- TruClear — Covidien LP · 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
- Versacut Tissue Morcellator — Lumenis · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TROKAMED GmbH
Sources (1)
- FDA UDI e8ac4f1e-9579-43af-90bb-92b35709754c 35 fields · synced May 31, 2026