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Phoenix Floppy Tip, Light Support Guidewire
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PG14300LF
Identity
- Trade Name
- Phoenix Floppy Tip, Light Support Guidewire EUDAMEDFDA UDIPhoenix Guidewire, Floppy Tip, Light Support EUDAMED
- Generic Name
- Peripheral vascular guidewire, manual FDA UDI
- Device Name
- Phoenix Guidewire EUDAMEDPhoenix 0.014" Guidewire FDA UDI
- Model / Reference
- PG14300LF EUDAMEDFDA UDI
- Description
- Phoenix 0.014" Guidewire FDA UDI
Identifiers
- Catalog Number
- PG14300LF FDA UDI
- Primary DI / UDI-DI
- 10845225002760 EUDAMEDFDA UDI00845225003647 EUDAMED
- Basic UDI-DI
- B-10845225002760 EUDAMED08452250BM40773 EUDAMED
- FDA Product Code
- DQX FDA UDI
- EMDN Code
- C04020202 PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
- GMDN Term
- Peripheral vascular guidewire, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1330 FDA UDI
- Market of Registration
- Belgium EUDAMEDNetherlands 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
Phoenix Floppy Tip, Light Support Guidewire by Volcano AtheroMed Inc. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-10845225002760 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-10845225002760 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Volcano AtheroMed Inc.
- EUDAMED SRN
- US-MF-000006912
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (3)
- EUDAMED 79ea2044-e725-403a-8a4f-72c3511d2969 61 fields · synced Jun 20, 2026
- EUDAMED d565172c-8334-4e56-a7e9-65444b780995 61 fields · synced May 18, 2026
- FDA UDI fe756b4a-7191-4684-bb00-09a958b100d8 36 fields · synced May 30, 2026