Kit composed of a PEEL-AWAY percutaneous introducer set + threshold cable
Ref F47508NG/33
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 | Number803300326222000008MV 18054751932928 | Date17 Sep 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- Withdrawn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
- Kit composed of a "PEEL-AWAY" percutaneous introducer set + threshold cable
- Model / Reference
- F47508NG/33
- Primary DI / UDI-DI
- 18054751932928
- Basic UDI-DI
- 803300326222000008MV
- EMDN Code
- V0599 Clinical procedures kits not included in other classes - other
- Device Class
- Class IIa
- Medical Purpose
- In the context of a temporary cardiac stimulation: the peelaway introducer intended for insertion of diagnostic and therapeutic devices into the vascular system; threshold cable intended for connection between a threshold analyzer (PSA) and a temporary cardiac lead
Manufacturer details
- EUDAMED SRN
- IT-PR-000048498
Other devices from FIAB S.p.A.
Properties
Other properties (1)
- Sterile: No