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Kirschner Wire ø 1.5 mm L 460 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 03.52.10.0463Ref 03.52.10.0465
Identity
- Trade Name
- Kirschner Wire ø 1.5 mm L 460 mm EUDAMEDKirschner Wire ø 1.5 mm L 460 mm EUDAMEDBIOPSYBELL FDA UDISpine Instruments FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- Kirschner Wire ø 1.5 mm L 460 mm EUDAMEDCEMENT INJECTION SYSTEMS FOR MINI-INVASIVE BONE SURGERY EUDAMEDKyphoplasty kirschner guide FDA UDI
- Model / Reference
- 03.52.10.0463 EUDAMED03.52.10.0465 EUDAMEDFDA UDIK-WIRE FDA UDI
- Description
- Kyphoplasty kirschner guide FDA UDI
Identifiers
- Catalog Number
- 03.52.10.0463 FDA UDI03.52.10.0465 FDA UDI
- Primary DI / UDI-DI
- 08033860020071 EUDAMEDFDA UDI08033860020095 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860020071 EUDAMED8033860SFFT01CU2 EUDAMEDB-08033860020095 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 UDILength — 460 Millimeter FDA UDIOuter Diameter — 1.5 Millimeter FDA UDI
Kirschner Wire ø 1.5 mm L 460 mm by Biopsybell Srl — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860020071 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860020071 | 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 (6)
- EUDAMED 955463db-f075-4dd1-8b45-7290cbb43515 61 fields · synced Jul 8, 2026
- EUDAMED 9c4450b8-42f4-4110-af2c-9027819c7fd7 61 fields · synced May 16, 2026
- EUDAMED bb0ed3d0-9afe-4267-9308-a98c1f172f3e 61 fields · synced May 18, 2026
- FDA UDI 5887e310-8482-4e64-8651-165c941038fc 36 fields · synced May 30, 2026
- FDA UDI 7fd24dcf-b298-4177-95a2-1aef96dd79a5 36 fields · synced May 30, 2026
- EUDAMED 3316fe08-cb54-44ad-beee-e0603186e819 61 fields · synced Jul 8, 2026