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Guidewire
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SGW-015-02Model SGW-XXX-xx510(k) K982559
Identity
- Trade Name
- Guidewire EUDAMEDFDA UDI
- Generic Name
- Peripheral vascular guidewire, manual FDA UDI
- Device Name
- Guidewires with a Maximum Length of 90cm EUDAMEDGuidewire FDA UDI
- Model / Reference
- SGW-XXX-xx EUDAMEDSGW-015-02 EUDAMEDFDA UDI
- Description
- Guidewire FDA UDI
Identifiers
- Catalog Number
- SGW-015-02 FDA UDI
- Primary DI / UDI-DI
- 00841268100565 EUDAMEDFDA UDI
- Basic UDI-DI
- 08412681Guidewires<90cm2K EUDAMED
- 510(k) Number
- K982559 FDA UDI
- FDA Product Code
- DQX FDA UDI
- EMDN Code
- C04020199 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES- OTHER EUDAMED
- GMDN Term
- Peripheral vascular guidewire, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1330 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.018 Inch FDA UDI
Guidewire by Galt Medical Corp. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982559 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K021990 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K031916 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08412681Guidewires<90cm2K | Class IIa | Unknown |
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Manufacturer
- Manufacturer
- Galt Medical Corp.
- EUDAMED SRN
- US-MF-000001777
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 2ee55b21-9c6e-4394-8d63-67b7f8abddc3 85 fields · synced Jun 18, 2026
- FDA UDI 9bad9cc5-7082-4f76-b130-a92d1c5f4d9f 37 fields · synced May 30, 2026
- FDA 510(k) K982559 1 fields · synced May 18, 2026