← Back to catalogue
Bone Access Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BAN1112CDT-BPRef BAN1310CTRef 03.52.10.0790Ref BAN1015CBRef BAN1112HCDBPWRef BAN1113CDBPRef BAN1112HCDTWRef BAN1112CDTRef BAN1212CBPRef BAN1310CDTRef BAN1012CDLRef BAN1312CBRef BAN1315CBRef BAN0812CDTRef BAN0812CDBBRef BAN1115CTRef BAN1112CDBPRef BAN1115CDTRef KKBAN1112CDTRef BAN1315CL
Identity
- Trade Name
- BONE ACCESS NEEDLE EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- CEMENT INJECTION SYSTEMS FOR MINI-INVASIVE BONE SURGERY EUDAMEDBONE ACCESS NEEDLE EUDAMEDFDA UDI
- Model / Reference
- BAN1112CDT-BP EUDAMEDBAN1310CT EUDAMED03.52.10.0790 EUDAMEDBAN1015CB EUDAMEDBAN1112HCDBPW EUDAMEDBAN1113CDBP EUDAMEDBAN1112HCDTW EUDAMEDBAN1112CDT EUDAMEDBAN1212CBP EUDAMEDBAN1310CDT EUDAMEDBAN1012CDL EUDAMEDBAN1312CB EUDAMEDBAN1315CB EUDAMEDBAN0812CDT EUDAMEDBAN0812CDBB EUDAMEDBAN1115CT EUDAMEDBAN1112CDBP EUDAMEDBAN1115CDT EUDAMEDKKBAN1112CDT EUDAMEDBAN1315CL EUDAMEDBONE ACCESS NEEDLE FDA UDI
- Description
- BONE ACCESS NEEDLE FDA UDI
Identifiers
- Catalog Number
- BAN0812CDT FDA UDIBAN1112HCDTW FDA UDIBAN1112HCDBPW FDA UDIBAN1115CDT FDA UDIBAN1112CDT FDA UDI
- Primary DI / UDI-DI
- 08033860027766 EUDAMED08033860024512 EUDAMED08033860040970 EUDAMED08033860019600 EUDAMED08033860022310 EUDAMEDFDA UDI08033860030575 EUDAMED08033860019365 EUDAMEDFDA UDI08033860024772 EUDAMEDFDA UDI08033860026660 EUDAMED08033860025885 EUDAMED08033860021276 EUDAMED08033860025786 EUDAMED08033860017040 EUDAMED08033860036300 EUDAMEDFDA UDI08033860030292 EUDAMED08033860019815 EUDAMED08033860018085 EUDAMED08033860017927 EUDAMEDFDA UDI08033860041724 EUDAMED08033860023140 EUDAMED
- Basic UDI-DI
- 8033860SFFT01CU2 EUDAMEDB-08033860019365 EUDAMEDB-08033860024772 EUDAMEDB-08033860017927 EUDAMEDB-08033860040970 EUDAMEDB-08033860036300 EUDAMEDB-08033860022310 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- A018003 NEEDLE INTRODUCERS EUDAMED
- GMDN Term
- Bone access channel 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 — 8 Gauge FDA UDILength — 120 Millimeter FDA UDINeedle Gauge — 11 Gauge FDA UDILength — 150 Millimeter FDA UDI
Bone Access Needle 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 | 8033860SFFT01CU2 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860SFFT01CU2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (31)
- EUDAMED 0d895337-418e-4c4c-916a-1fd55842d71f 61 fields · synced Sep 18, 2026
- EUDAMED b21037b3-7757-415d-a50a-63c201bac92b 61 fields · synced May 16, 2026
- EUDAMED a5412019-ffcd-4c0c-88c5-6bfd5fabdec8 61 fields · synced May 17, 2026
- EUDAMED 9c8bfe81-13aa-4250-8c1d-19fa70984195 61 fields · synced May 17, 2026
- EUDAMED be7281db-3157-4616-a6c2-dc59ec56441a 61 fields · synced May 17, 2026
- EUDAMED 456dc533-521b-44f3-a623-f2b58c1f2fb4 61 fields · synced May 17, 2026
- EUDAMED 52736715-6716-45a2-88f9-9066d41efff2 61 fields · synced May 17, 2026
- EUDAMED ddb94bd2-93a2-4842-a989-c42a3a5cdb0d 61 fields · synced May 17, 2026
- EUDAMED 1a1efa09-f0e7-4210-8ad2-e9105785daa9 61 fields · synced May 17, 2026
- EUDAMED d18ecd59-5f7f-46a4-83bb-e0ac10311f9a 61 fields · synced May 17, 2026
- EUDAMED 26790b8c-250d-430a-ac0e-d5a5e60d0db8 61 fields · synced May 17, 2026
- EUDAMED e234011b-0bd1-46ab-8795-a2064406a90b 61 fields · synced May 17, 2026
- EUDAMED 7ebd2cdf-645c-41d2-b316-1037d229886a 61 fields · synced May 17, 2026
- EUDAMED 337176c1-549e-4f0c-9cc2-afc7a5abe0ac 61 fields · synced May 18, 2026
- EUDAMED 945cbb49-8d79-41ed-b515-f7f0f2140314 61 fields · synced May 18, 2026
- EUDAMED 92f691d3-360a-415b-825c-477635a3beb3 61 fields · synced May 18, 2026
- EUDAMED 990b26e1-3e4b-421f-93d7-8a58a3c9b9c9 61 fields · synced May 18, 2026
- EUDAMED 18d216b8-a7f6-4863-9746-82a826bbc869 61 fields · synced May 18, 2026
- EUDAMED 01b06e5a-75bb-4129-9adf-72a4d4010496 61 fields · synced May 18, 2026
- EUDAMED 86d2a757-a68c-4a2e-a500-a28cfdc5ae05 61 fields · synced May 19, 2026
- FDA UDI e8348689-9b29-4296-aff2-f88d3bf868ca 36 fields · synced May 29, 2026
- FDA UDI 9d295a81-80d4-4279-bf58-aecf18c656dc 36 fields · synced May 30, 2026
- FDA UDI c7333b6e-16a3-4208-80a8-700da7ab14a1 36 fields · synced May 30, 2026
- FDA UDI fd33ebbe-bdea-43da-8968-e7622f8cf8b0 36 fields · synced May 30, 2026
- FDA UDI 82538325-60df-4e3a-9e32-3eb0399bb9ce 36 fields · synced May 30, 2026
- EUDAMED 7f456332-149a-4a86-a97d-161113769490 61 fields · synced Jun 20, 2026
- EUDAMED 9db97a50-8786-49d5-aba7-c28883d84aef 61 fields · synced Jul 16, 2026
- EUDAMED 85b3e43e-5939-4cc0-bf46-fb297322d3d8 61 fields · synced Jul 20, 2026
- EUDAMED 20fd1f9f-c515-4a87-b43d-f5edcbf9e82b 61 fields · synced Jul 23, 2026
- EUDAMED 15cbf56a-900a-4a42-9713-b253bffb1b16 61 fields · synced Jul 24, 2026
- EUDAMED 42703c58-4eaa-4bb4-90ef-f5b2ca750e5a 61 fields · synced Aug 4, 2026