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Kirschner Wire ø 1.5 mm L 460 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 03.52.10.0464
Identity
- Trade Name
- Kirschner Wire ø 1.5 mm L 460 mm EUDAMEDKirschner Wire ø 1.5 mm L 460 mm EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- CEMENT INJECTION SYSTEMS FOR MINI-INVASIVE BONE SURGERY EUDAMEDKirschner Wire ø 1.5 mm L 460 mm EUDAMEDKyphoplasty kirschner guide FDA UDI
- Model / Reference
- 03.52.10.0464 EUDAMEDK-WIRE FDA UDI
- Description
- Kyphoplasty kirschner guide FDA UDI
Identifiers
- Catalog Number
- 03.52.10.0464 FDA UDI
- Primary DI / UDI-DI
- 08033860020088 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860SFFT01CU2 EUDAMEDB-08033860020088 EUDAMED
- FDA Product Code
- GDF FDA UDI
- EMDN Code
- A018003 NEEDLE INTRODUCERS EUDAMED
- GMDN Term
- Bone access channel kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy 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
Yes
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
- Guidewire Diameter — 1.50 Millimeter FDA UDIGuidewire Length — 460 Millimeter FDA UDI
Kirschner Wire ø 1.5 mm L 460 mm by Biopsybell Srl — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860SFFT01CU2 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860SFFT01CU2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED 850e56cd-2b3f-4fd6-b08c-18f15d454d0e 61 fields · synced Jul 14, 2026
- FDA UDI 83f5e8fb-7c75-47e2-a747-497eaedc034c 36 fields · synced May 29, 2026
- EUDAMED a835b23f-b36f-4244-b1d2-8a45ebf3ff8b 61 fields · synced Jun 19, 2026