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Osteobell "t"
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref OB1110CTRef OB0915TRef OBEC0810CTRef OB1310CTRef OB1315T
Identity
- Trade Name
- OSTEOBELL "T" EUDAMEDOSTEOBELL “T” EUDAMEDBIOPSYBELL SRL FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Device Name
- OSTEOBELL "T" EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMEDOSTEOBELL “T” EUDAMEDNEEDLE FOR BONE MARROW BIOPSY FDA UDI
- Model / Reference
- OB1110CT EUDAMEDOB0915T EUDAMEDOBEC0810CT EUDAMEDOB1310CT EUDAMEDOB1315T EUDAMEDOSTEOBELL "T" FDA UDI
- Description
- NEEDLE FOR BONE MARROW BIOPSY FDA UDI
Identifiers
- Catalog Number
- OB1315T FDA UDIOB0915T FDA UDI
- Primary DI / UDI-DI
- 08033860041069 EUDAMED08033860000745 EUDAMEDFDA UDI08033860001940 EUDAMED08033860041465 EUDAMED08033860000783 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860041069 EUDAMED8033860BIOEFT01U5 EUDAMEDB-08033860000745 EUDAMEDB-08033860000783 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 — 13 Gauge FDA UDILength — 150 Millimeter FDA UDINeedle Gauge — 09 Gauge 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-08033860041069 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860041069 | 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 (10)
- EUDAMED 23fb398a-982f-4b0e-a0bc-70b48b2a34bb 61 fields · synced Jul 29, 2026
- EUDAMED 6573d103-338f-4d62-89a3-5fe7e580f03b 61 fields · synced May 17, 2026
- EUDAMED 9da99ed1-4cf2-4c62-8836-edec53c1f3b4 61 fields · synced May 18, 2026
- EUDAMED a85c65f5-7552-4034-9a27-54262b9c6f52 61 fields · synced May 18, 2026
- EUDAMED 68969521-6542-4ec7-b1e1-4fc5663c6731 61 fields · synced May 18, 2026
- EUDAMED 368649f9-c23a-478e-bbd0-976b9c5dd5af 61 fields · synced May 18, 2026
- FDA UDI f621e428-9fb1-44f1-a6aa-45eefb4ce121 37 fields · synced May 30, 2026
- FDA UDI 4d83c837-873d-4409-b366-b5c34f5adcaf 37 fields · synced May 30, 2026
- EUDAMED da8a09e6-3aca-4128-9094-8eb138914046 61 fields · synced Jul 8, 2026
- EUDAMED 56188cdb-bbb4-42e8-92de-6e7c7ae8c6bc 61 fields · synced Jul 17, 2026