AVANTI™+ Transradial Introducer Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- AVANTI™+ Transradial Introducer Kit EUDAMEDAVANTI FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- Catheter Sheath Introducer - AVANTI™+ Transradial Introducer Kit EUDAMEDSI AVANTI+ TRANSRAD KIT 11CM FDA UDI
- Model / Reference
- 504-615Z EUDAMED504615Z FDA UDI
- Description
- SI AVANTI+ TRANSRAD KIT 11CM FDA UDI
Identifiers
- Catalog Number
- 504615Z FDA UDI
- Primary DI / UDI-DI
- 10705032010276 EUDAMEDFDA UDI
- Basic UDI-DI
- 07050320000000000000011C6 EUDAMED
- 510(k) Number
- K962746 FDA UDI
- FDA Product Code
- DRE FDA UDI
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
- GMDN Term
- Haemostasis valve FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1310 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
Yes
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Vascular catheter introduction set, nonimplantable
AVANTI™+ Transradial Introducer Kit by Cordis US Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular catheter introduction set, nonimplantable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 07050320000000000000011C6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cordis US Corp.
- EUDAMED SRN
- US-MF-000020031
- Authorised Representative
- Cordis Cashel IE-AR-000017793
Sources (2)
- EUDAMED ae2dbf57-d1c7-43ff-82cc-78ab7e0117b9 61 fields · synced Oct 6, 2026
- FDA UDI 77f87b0b-aa2e-43fb-ba0f-b30ed5142b17 36 fields · synced May 30, 2026