Identity
- Trade Name
- OSTEOBELL "T" EUDAMEDBIOPSYBELL SRL FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Device Name
- OSTEOBELL "T" EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMEDNEEDLE FOR BONE MARROW BIOPSY FDA UDI
- Model / Reference
- OB1110T EUDAMEDOSTEOBELL "T" FDA UDI
- Description
- NEEDLE FOR BONE MARROW BIOPSY FDA UDI
Identifiers
- Catalog Number
- OB1110T FDA UDI
- Primary DI / UDI-DI
- 08033860000028 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860000028 EUDAMED8033860BIOEFT01U5 EUDAMED
- 510(k) Number
- K130616 FDA UDI
- FDA Product Code
- FCG FDA UDIKNW FDA UDI
- EMDN Code
- A01020201 ILIAC-STERNAL BIOPSY NEEDLES AND KITS EUDAMED
- GMDN Term
- Bone marrow biopsy procedure kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 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
No
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 UDILength — 100 Millimeter FDA UDI
Osteobell "t" 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-08033860000028 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860000028 | 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 be9e61c3-c043-4f27-bf3d-6a704de9c560 61 fields · synced Jul 26, 2026
- EUDAMED 500dec9d-6de2-4b79-a375-e9fed5400460 61 fields · synced May 19, 2026
- FDA UDI edf17904-f042-4a4d-9d65-84bb02039ad6 37 fields · synced May 27, 2026