Identity
- Trade Name
- OSTEOPEARL EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDOSTEOPEARL EUDAMEDOsteoPearl™ Bone Filler, 8G Orthopedic procedure with Biological Allograft Chain FDA UDI
- Model / Reference
- 100.438 EUDAMEDOSTEOPEARL™ BONE FILLER 8G FDA UDI
- Description
- OsteoPearl™ Bone Filler, 8G Orthopedic procedure with Biological Allograft Chain FDA UDI
Identifiers
- Catalog Number
- 100.438 FDA UDI
- Primary DI / UDI-DI
- 08033860044954 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860044954 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS 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 — 182 Millimeter FDA UDI
Category: Intraosseous infusion kit
Osteopearl by Biopsybell Srl — Class IIa — MDD, MDR, 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/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 dffb1798-fe5d-4ae4-bc83-08dd08ba1a08 61 fields · synced Jun 19, 2026
- FDA UDI 36d0069e-e5a9-47ae-b2be-63d0c725039d 36 fields · synced May 30, 2026
- EUDAMED 18e176f6-30aa-4b4f-bcfc-68ac1832ad72 61 fields · synced Jun 19, 2026