Identity
- Trade Name
- R-100 EUDAMEDFDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter extractor, reusable FDA UDI
- Device Name
- R-100 EUDAMEDR-100 Pullback Device FDA UDI
- Model / Reference
- 804547001 EUDAMEDFDA UDI
- Description
- R-100 Pullback Device FDA UDI
Identifiers
- Catalog Number
- 804547001 FDA UDI
- Primary DI / UDI-DI
- 00184360000327 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00184360000327 EUDAMED
- 510(k) Number
- K962293 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- C0180 ARTERO-VENOUS SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Intravascular ultrasound imaging catheter extractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
R-100 by Volcano Corporation — Class I — 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-00184360000327 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (2)
- EUDAMED 83682a20-1a11-4158-8f7c-541d05d4dc1b 61 fields · synced Jun 19, 2026
- FDA UDI 31b086f6-4147-446f-8c29-8627d17d0ff4 35 fields · synced May 30, 2026