Identity
- Trade Name
- OSTEOBELL EXPLANT EUDAMEDBIOPSYBELL SRL FDA UDI
- Generic Name
- Bone marrow explant needle FDA UDI
- Device Name
- OSTEOBELL EXPLANT EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMEDNEEDLE FOR BONE MARROW EXPLANT FDA UDI
- Model / Reference
- OBE1111TC EUDAMEDOSTEOBELL EXPLANT FDA UDI
- Description
- NEEDLE FOR BONE MARROW EXPLANT FDA UDI
Identifiers
- Catalog Number
- OBE1111TC FDA UDI
- Primary DI / UDI-DI
- 08033860002107 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860002107 EUDAMED8033860BIOEFT01U5 EUDAMED
- 510(k) Number
- K130616 FDA UDI
- FDA Product Code
- FCG FDA UDIKNW FDA UDI
- EMDN Code
- A01020202 BONE MARROW EXPLANT NEEDLES AND KITS EUDAMED
- GMDN Term
- Bone marrow explant needle 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 — 110 Millimeter FDA UDI
Osteobell Explant 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-08033860002107 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860002107 | 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 3707009f-8afb-45fa-9d14-8320ce5743d8 61 fields · synced Aug 4, 2026
- EUDAMED df84275b-4bc7-43da-9c4a-d5a3609c7eb3 61 fields · synced May 19, 2026
- FDA UDI 34bcdcd8-5038-4a76-bdf2-d621f65ce5ff 37 fields · synced May 30, 2026