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MEDRAD® Centargo Replacement Spike
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref CENT-RS
Identity
- Trade Name
- MEDRAD® Centargo Replacement Spike EUDAMEDFDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- MEDRAD® Centargo Disposables EUDAMEDASSY,SPIKE,CENTARGO,US FDA UDI
- Model / Reference
- CENT-RS EUDAMEDFDA UDI
- Description
- ASSY,SPIKE,CENTARGO,US FDA UDI
Identifiers
- Catalog Number
- CENT-RS FDA UDI
- Primary DI / UDI-DI
- 09345390002953 EUDAMED09345390002717 FDA UDI
- Basic UDI-DI
- 934539000TFCN-0100UQ EUDAMED
- FDA Product Code
- DXT FDA UDIIZQ FDA UDI
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
- GMDN Term
- Angiographic syringe FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Angiographic syringe
MEDRAD® Centargo Replacement Spike by Imaxeon Pty Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Imaxeon Pty Ltd
Sources (2)
- FDA UDI 5facd61b-e911-42cd-bfde-180b3e392081 37 fields · synced Jul 9, 2026
- EUDAMED 962b040c-293c-4f0a-9cad-fe679b4b60a8 61 fields · synced Jul 9, 2026