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Bard™ Solo Flex Urology Wire (.038 NiTi, Angled)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HW38FA
Identity
- Trade Name
- Bard™ Solo Flex Urology Wire (.038 NiTi, Angled) EUDAMEDSOLO FLEX Hybrid Guidewires FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- Bard™ Solo Flex Urology Wire (.038 NiTi, Angled) EUDAMED
- Model / Reference
- HW38FA EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816840020364 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816840020364 EUDAMED
- FDA Product Code
- EZB FDA UDI
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
- GMDN Term
- Gastro-urological guidewire, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.5130 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
No
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
Bard™ Solo Flex Urology Wire (.038 NiTi, Angled) by Heraeus Medical Components Llc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00816840020364 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Heraeus Medical Components LLC
- EUDAMED SRN
- US-MF-000018306
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 20ab7dba-b0c7-4295-a157-aa86abefe522 61 fields · synced Jul 25, 2026
- FDA UDI af06ef48-e3a7-4f43-85bb-3ce92bbb3105 32 fields · synced May 30, 2026