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Verrata Pressure Guide Wire
EUDAMEDFDA UDIClass III (EU MDR)
Ref 10185JRef 10185
Identity
- Trade Name
- Verrata Pressure Guide Wire EUDAMEDVerrata Pressure Guide Wire 185cm FDA UDIVerrata Pressure Guide Wire 185cm JTIP FDA UDI
- Generic Name
- Catheter-tip transducer, pressure FDA UDI
- Device Name
- Verrata EUDAMED
- Model / Reference
- 10185J EUDAMEDFDA UDI10185 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845225002442 EUDAMEDFDA UDI00845225002435 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225002442 EUDAMEDB-00845225002435 EUDAMED
- 510(k) Number
- K131288 FDA UDI
- FDA Product Code
- DXO FDA UDIDQX FDA UDI
- EMDN Code
- C04030101 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
- GMDN Term
- Catheter-tip transducer, pressure FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2870 FDA UDI870.1330 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Verrata Pressure Guide Wire by Volcano Corporation — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00845225002442 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (4)
- EUDAMED d126d38e-b0fb-4441-8621-64478a4a052b 61 fields · synced Jul 8, 2026
- FDA UDI 91586c03-4773-4840-8b38-1526b027402e 33 fields · synced May 30, 2026
- FDA UDI 106fecd1-5a2d-40d8-bfdd-0ea5c57a38e9 33 fields · synced May 30, 2026
- EUDAMED f98e1aaf-9ba0-41d2-8405-b48f6f5d8a0c 61 fields · synced Jun 20, 2026