Identity
- Trade Name
- OSTEOPEARL EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDOsteoPearl™ Access Cannula & Beveled Tip Trocar, 8G Orthopedic procedure with Biological Allograft Chain FDA UDI
- Model / Reference
- 100.434 EUDAMEDOSTEOPEARL™ ACCESS CANNULA & BEVELED TIP TROCAR 8G FDA UDI
- Description
- OsteoPearl™ Access Cannula & Beveled Tip Trocar, 8G Orthopedic procedure with Biological Allograft Chain FDA UDI
Identifiers
- Catalog Number
- 100.434 FDA UDI
- Primary DI / UDI-DI
- 08033860044916 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- K010301 SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON EUDAMED
- GMDN Term
- Bone graft delivery 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 — 08 Gauge FDA UDILength — 120 Millimeter FDA UDI
Osteopearl by Biopsybell Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (2)
- EUDAMED 2adada31-4c9a-4b92-bf29-13d4a4172098 61 fields · synced Jul 15, 2026
- FDA UDI 9a2acbae-056c-4560-9a5b-72af3da5449f 36 fields · synced May 30, 2026