Eu Mdr
Eu Md Class 2a
On The Market
FocalPak
The Focalpak is an accessory of the Focal One. It is designed for acoustic coupling and cooling between tissues and endorectal probe.
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 03661690000243
- Basic UDI-DI Code
- 3661690FOCALPAK2B
- Reference
- EDP 901400
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
Additional Description
The FocalPak is a disposable device for Focal One system. The Focalpak® contains: - FocalPak set (manufactured by EDAP TMS France), - Acoustic Gel, - Balloon/Transducer Cover, - Syringe.
Medical Purpose
The Focalpak is an accessory of the Focal One. It is designed for acoustic coupling and cooling between tissues and endorectal probe.
CND Nomenclature Codes
| Code | Description |
|---|---|
| U1299 | SINGLE-USE UROGENITAL INSTRUMENTATION (NON-ENDOSCOPIC) - OTHER |
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