Identity
- Trade Name
- OSTEOPEARL EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDOSTEOPEARL EUDAMEDOsteoPearl™ Access Cannula & Diamond Tip Trocar, 8G for Orthopedic procedure with Biological Allograft Chain FDA UDIOsteoPearl™ Drill, 8G Orthopedic procedure with Biological Allograft Chain FDA UDI
- Model / Reference
- 100.436 EUDAMED100.432 EUDAMEDOSTEOPEARL™ ACCESS CANNULA & DIAMOND TIP TROCAR 8G FDA UDIOSTEOPEARL™ DRILL 8G FDA UDI
- Description
- OsteoPearl™ Access Cannula & Diamond Tip Trocar, 8G for Orthopedic procedure with Biological Allograft Chain FDA UDIOsteoPearl™ Drill, 8G Orthopedic procedure with Biological Allograft Chain FDA UDI
Identifiers
- Catalog Number
- 100.432 FDA UDI100.436 FDA UDI
- Primary DI / UDI-DI
- 08033860044930 EUDAMEDFDA UDI08033860044893 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860044930 EUDAMEDB-08033860044893 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 UDILength — 182 Millimeter FDA UDI
Osteopearl 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 (6)
- EUDAMED f562f146-bede-447f-9089-8fcb49875f3e 61 fields · synced Jul 27, 2026
- EUDAMED 419d6f87-b5f5-4e05-809c-f94513eda85c 61 fields · synced May 19, 2026
- FDA UDI 41af5677-dc9b-4dae-a0b0-91d16cac7c4a 36 fields · synced May 30, 2026
- FDA UDI 630eb8df-5573-40cd-89ce-39cd3b310fb2 36 fields · synced May 30, 2026
- EUDAMED 84980aa1-5167-4e43-b999-19f50238e296 61 fields · synced Jul 21, 2026
- EUDAMED 1e49eaf2-668b-45e9-bfe0-e0cb32815d04 61 fields · synced Jul 27, 2026