Identity
- Trade Name
- KYPHOKIT BONE FILLER EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Vertebral body cement cannula FDA UDI
- Device Name
- KYPHOKIT BONE FILLER EUDAMEDKYPHOPLASTY SYSTEMS EUDAMEDKYPHOPLASTY BONE FILLER KIT FDA UDI
- Model / Reference
- KK11-FIL EUDAMEDKYPHOKIT BONE FILLER FDA UDI
- Description
- KYPHOPLASTY BONE FILLER KIT FDA UDI
Identifiers
- Catalog Number
- KK11-FIL FDA UDI
- Primary DI / UDI-DI
- 08033860023102 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860023102 EUDAMED8033860KYPFT05A9T EUDAMED
- FDA Product Code
- OAR FDA UDI
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
- GMDN Term
- Vertebral body cement cannula FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4200 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
Category: Intraosseous infusion kit
Kyphokit Bone Filler by Biopsybell Srl — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-08033860023102 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860023102 | 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 a445fe7e-6a8b-457c-9d27-8f8c51ad6930 61 fields · synced Jul 16, 2026
- EUDAMED 34e93abd-15e9-4225-913e-95ceda87e67b 61 fields · synced May 19, 2026
- FDA UDI 82b3886e-8813-4336-849e-e1a0937a6110 36 fields · synced May 30, 2026