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Kirschner Wire ø 1.4 mm L 400 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 03.75.10.0205Ref 03.75.10.0203Ref 03.75.10.0204Ref 03.75.10.0206
Identity
- Trade Name
- Kirschner Wire ø 1.4 mm L 400 mm EUDAMEDKirschner Wire ø 1.4 mm L 400 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 1.4 mm L 400 mm EUDAMEDKyphoplasty kirschner guide FDA UDI
- Model / Reference
- 03.75.10.0205 EUDAMED03.75.10.0203 EUDAMED03.75.10.0204 EUDAMED03.75.10.0206 EUDAMEDK-WIRE FDA UDI
- Description
- Kyphoplasty kirschner guide FDA UDI
Identifiers
- Catalog Number
- 03.75.10.0205 FDA UDI03.75.10.0206 FDA UDI
- Primary DI / UDI-DI
- 08033860025434 EUDAMEDFDA UDI08033860025410 EUDAMED08033860025427 EUDAMED08033860025441 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860SFFT01CU2 EUDAMEDB-08033860025441 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 — 1.40 Millimeter FDA UDIGuidewire Length — 400 Millimeter FDA UDI
Kirschner Wire ø 1.4 mm L 400 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 (7)
- EUDAMED 01b24a7a-d956-45d7-880b-80dda31e1c5b 61 fields · synced Sep 17, 2026
- EUDAMED 0f0e9672-e19a-4710-9688-91691fb7c62e 61 fields · synced May 17, 2026
- EUDAMED 1e2a1599-6fa6-43c4-b602-0b9a2f726830 61 fields · synced May 18, 2026
- EUDAMED e02a1b4f-0c94-46ca-85b1-b0d222d2d3bd 61 fields · synced May 19, 2026
- FDA UDI ca04c031-879e-4bdc-b858-daf09d38904f 36 fields · synced May 26, 2026
- FDA UDI 4fefc7ae-a5bf-4bc3-83f3-130a6e09581e 36 fields · synced May 30, 2026
- EUDAMED 08399de3-26b5-4e48-b7d7-400f7210927c 61 fields · synced Jul 9, 2026