Identity
- Trade Name
- Quick-Cross support catheter EUDAMEDFDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Quick-Cross Support Catheter EUDAMED
- Model / Reference
- 518-033 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 518-033 FDA UDI
- Primary DI / UDI-DI
- 00813132029333 EUDAMEDFDA UDI
- Basic UDI-DI
- 081313202BM384MD EUDAMED
- 510(k) Number
- K033678 FDA UDI
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C0104020204 PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS EUDAMED
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 90 Centimeter FDA UDILumen/Inner Diameter — 0.018 Inch FDA UDI
Quick-Cross support catheter by Philips Image Guided Therapy Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081313202BM384MD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Image Guided Therapy Corporation
- EUDAMED SRN
- US-MF-000018632
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 053ebd50-55dc-438d-abb5-a48386bec6ad 61 fields · synced Jun 18, 2026
- FDA UDI 990d183b-79e1-45be-a9b7-a32fa8a36876 37 fields · synced May 30, 2026