Identity
- Trade Name
- KYPHOKIT KIRSCHNER GUIDE EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- KYPHOKIT KIRSCHNER GUIDE EUDAMEDKYPHOPLASTY SYSTEMS EUDAMEDKYPHOPLASTY KIRSCHNER GUIDE FDA UDI
- Model / Reference
- KK11-FGP EUDAMEDKYPHOKIT KIRSCHNER GUIDE FDA UDI
- Description
- KYPHOPLASTY KIRSCHNER GUIDE FDA UDI
Identifiers
- Catalog Number
- KK11-FGP FDA UDI
- Primary DI / UDI-DI
- 08033860025922 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860025922 EUDAMED8033860KYPFT05A9T EUDAMED
- FDA Product Code
- GDF 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
- 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
- Needle Gauge — 11 Gauge FDA UDI
Kyphokit Kirschner Guide 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-08033860025922 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860025922 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED 5aec8c18-ff5e-40bc-9d48-388974a3366d 61 fields · synced Jul 8, 2026
- EUDAMED 64a678cc-6d36-4b9f-a9d1-14aaa3d58798 61 fields · synced May 19, 2026
- FDA UDI efc20f9d-71b8-4fa0-802f-e9b7bb9d699f 36 fields · synced May 29, 2026