Identity
- Trade Name
- Osty-Core Bone Biopsy EUDAMEDOsty-Core™ FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- Osty-Core Bone Biopsy Needle EUDAMEDOsty-Core™ Bone Biopsy Needle 16ga x 16.5cm FDA UDI
- Model / Reference
- OBN16165 EUDAMEDFDA UDI
- Description
- Osty-Core™ Bone Biopsy Needle 16ga x 16.5cm FDA UDI
Identifiers
- Catalog Number
- OBN16165 FDA UDI
- Primary DI / UDI-DI
- 20886333003192 EUDAMED00886333003198 FDA UDI
- Basic UDI-DI
- B-20886333003192 EUDAMED
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020201,A01020202 EUDAMED
- GMDN Term
- Bone marrow biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Category: Bone marrow biopsy needle, single-use
Osty-Core™ by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Bone marrow biopsy needle, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (2)
- FDA UDI 8f0e1509-4b12-4e27-ae60-5f64f07732c9 37 fields · synced Jun 18, 2026
- EUDAMED 5fdff82e-aa96-43e2-a75c-239320468c93 61 fields · synced Jun 18, 2026