Kit RF per FBSS
by Advanced Medical Systems Group S.R.L.
Ref AMS/RF14-P-SK
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805424725KITNAVIGATORCZ 08054247257859 | Date1 Oct 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sistema assemblato con elettrocatetere orientabile
- Model / Reference
- AMS/RF14-P-SK
- Primary DI / UDI-DI
- 08054247257859
- Basic UDI-DI
- 805424725KITNAVIGATORCZ
- EMDN Code
- K020399 Devices for surgery with radiofrequency generator, single-use - other
- Device Class
- Class IIb
- Medical Purpose
- Procedure di peridurolisi e/o adesiolisi percutanea del canale vertebrale. Tale procedura può essere associata alla possibilità di trattare con segnali elettrici pulsata (Pulsed Radio Frequency PRF) le radici e i gangli in uscita dai forami spinali liberati. Questa procedura chirurgica è indicata per pazienti con sintomatologie legate a: - FBSS - Stenosi Spinale - Chronic Low Back Pain - Radicolopatia - Nevralgia post-herpetica
Manufacturer details
- EUDAMED SRN
- IT-PR-000058313
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Properties
Other properties (1)
- Sterile: No