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Kyphokit Working Cannula And Bevel/Trocar Tip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref KK11-WTRB
Identity
- Trade Name
- KYPHOKIT WORKING CANNULA AND BEVEL/TROCAR TIP EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- KYPHOKIT WORKING CANNULA AND BEVEL/TROCAR TIP EUDAMEDKYPHOPLASTY SYSTEMS EUDAMEDKYPHOPLASTY WORKING CANNULA AND BEVEL/TROCAR TIP FDA UDI
- Model / Reference
- KK11-WTRB EUDAMEDKYPHOKIT WORKING CANNULA AND BEVEL/TROCAR TIP FDA UDI
- Description
- KYPHOPLASTY WORKING CANNULA AND BEVEL/TROCAR TIP FDA UDI
Identifiers
- Catalog Number
- KK11-WTRB FDA UDI
- Primary DI / UDI-DI
- 08033860038830 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860038830 EUDAMED8033860KYPFT05A9T EUDAMED
- FDA Product Code
- OCJ FDA UDI
- EMDN Code
- K010301 SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON EUDAMED
- GMDN Term
- Bone access channel kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 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
- Needle Gauge — 11 Gauge FDA UDILength — 120 Millimeter FDA UDI
Kyphokit Working Cannula And Bevel/Trocar Tip 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-08033860038830 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860038830 | 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 685f1d71-3688-45cd-a178-f27023435d5e 61 fields · synced Jul 10, 2026
- EUDAMED 84b55030-0647-452b-802c-d072cb06ea3d 61 fields · synced May 17, 2026
- FDA UDI 0ea56501-195f-401f-a796-b7d70aa1ad51 36 fields · synced May 30, 2026