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Aristotle 24 Guidewire
EUDAMEDFDA UDIClass III (EU MDR)
Ref A24-200-002Model 00897
Identity
- Trade Name
- Aristotle 24 Guidewire EUDAMEDAristotle FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- Aristotle 24 Guidewire EUDAMEDGuidewire-Standard FDA UDI
- Model / Reference
- 00897 EUDAMEDA24-200-002 EUDAMED24-200-002 FDA UDI
- Description
- Guidewire-Standard FDA UDI
Identifiers
- Catalog Number
- A24-200-002 FDA UDI
- Primary DI / UDI-DI
- 00818075010134 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00818075010134 EUDAMED
- 510(k) Number
- K192783 FDA UDI
- FDA Product Code
- DQX FDA UDIMOF FDA UDI
- EMDN Code
- C04030101 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1330 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Aristotle 24 Guidewire by Scientia Vascular, Inc. — 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-00818075010134 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Scientia Vascular, Inc.
- EUDAMED SRN
- US-MF-000018661
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 46a5b42a-3572-4bb4-9ba2-bb46811d9a7e 61 fields · synced Jun 1, 2026
- FDA UDI 1da18e79-15b3-4d00-bd59-7029a7574d27 37 fields · synced May 30, 2026