Identity
- Trade Name
- KYPHOKIT BONE ACCESS NEEDLE EUDAMEDKYPHOKIT BONE ACCESS NEEDLE EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDKYPHOKIT BONE ACCESS NEEDLE EUDAMEDKYPHOPLASTY BONE ACCESS NEEDLE FDA UDI
- Model / Reference
- KK11-OB EUDAMEDKYPHOKIT BONE ACCESS NEEDLE FDA UDI
- Description
- KYPHOPLASTY BONE ACCESS NEEDLE FDA UDI
Identifiers
- Catalog Number
- KK11-OB FDA UDI
- Primary DI / UDI-DI
- 08033860025915 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860025915 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 UDI
Kyphokit Bone Access Needle 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 | 8033860KYPFT05A9T | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860KYPFT05A9T | 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 2f6b2960-9908-4578-8462-fe0d26ed3855 61 fields · synced Jul 18, 2026
- EUDAMED a83ded8f-0f54-42da-955d-11903be93283 61 fields · synced May 17, 2026
- FDA UDI a255ba65-841d-42be-8e51-3fe457250aa6 36 fields · synced May 30, 2026