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Osteobell Explant
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref OBE1312TRef OBE1111T-PRRef OBE0815T
Identity
- Trade Name
- OSTEOBELL EXPLANT EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDNEEDLE FOR BONE MARROW EXPLANT FDA UDI
- Model / Reference
- OBE1312T EUDAMEDOBE1111T-PR EUDAMEDOBE0815T EUDAMEDOSTEOBELL EXPLANT FDA UDI
- Description
- NEEDLE FOR BONE MARROW EXPLANT FDA UDI
Identifiers
- Catalog Number
- OBE0815T FDA UDI
- Primary DI / UDI-DI
- 08033860015077 EUDAMED08033860045135 EUDAMED08033860025083 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMED
- 510(k) Number
- K130616 FDA UDI
- FDA Product Code
- FCG FDA UDI
- EMDN Code
- A01020202 BONE MARROW EXPLANT NEEDLES AND KITS EUDAMED
- GMDN Term
- Soft-tissue biopsy procedure kit, non-medicated 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
No
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 150 Millimeter FDA UDINeedle Gauge — 8 Gauge FDA UDI
Category: Bone marrow biopsy needle, single-use
Osteobell Explant by Biopsybell Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone marrow biopsy needle, single-use.
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class II
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class I
- MEDBONE — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy — Argon Medical Devices, Inc. · Class I
- Monoject — Cardinalhealth · Class II
- MEDLOCK — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy Needle, RBN-116 — RANFAC CORP. · Class II
- Faset — Dio Medical Co., Ltd. · U
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8033860BIOEFT01U5 | 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 (4)
- EUDAMED d86e1b92-d41e-4228-9abe-b81605fcdc24 61 fields · synced Jul 15, 2026
- EUDAMED 5fa69259-47e1-421c-953d-6707c25700d5 61 fields · synced May 17, 2026
- EUDAMED 2d4fbe6f-c243-4855-8473-38d302ebe109 61 fields · synced May 18, 2026
- FDA UDI a92686aa-66b4-4ba8-aed9-dc0d02b8d281 38 fields · synced May 30, 2026