Identity
- Trade Name
- RevoWave PX EUDAMEDRevoWave™ FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- 0.035 Hard FDA UDI
- Model / Reference
- RWHJ-3545SJ EUDAMEDFDA UDI
- Description
- 0.035 Hard FDA UDI
Identifiers
- Catalog Number
- RWHJ-3545SJ FDA UDI
- Primary DI / UDI-DI
- 04545428038366 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04545428038366 EUDAMED
- FDA Product Code
- OCY FDA UDI
- EMDN Code
- G030499,G030899,U0601,V9018 EUDAMED
- GMDN Term
- Gastro-urological guidewire, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 450 Centimeter FDA UDI
RevoWave PX by Piolax Medical Devices, Inc. — Class IIa — 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-04545428038366 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Piolax Medical Devices, Inc.
- EUDAMED SRN
- JP-MF-000007059
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED ec89fbce-2698-41d8-a65a-95b6e429959d 61 fields · synced Jul 8, 2026
- FDA UDI a9d48f6e-88e4-4755-b184-0ca52713b7a8 36 fields · synced May 30, 2026