Identity
- Trade Name
- Bone Marrow Biopsy Needle EUDAMEDFDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- Bone Marrow Biopsy Needle EUDAMEDBone Marrow Biopsy Needle 13ga x 2-1/2in FDA UDIBone Marrow Biopsy Needle 13ga x 4in FDA UDI
- Model / Reference
- DBMNJ1304 EUDAMEDFDA UDIDBMNJ13025 FDA UDI
- Description
- Bone Marrow Biopsy Needle 13ga x 2-1/2in FDA UDIBone Marrow Biopsy Needle 13ga x 4in FDA UDI
Identifiers
- Catalog Number
- DBMNJ13025 FDA UDIDBMNJ1304 FDA UDI
- Primary DI / UDI-DI
- 20886333001501 EUDAMED00886333001491 FDA UDI00886333001507 FDA UDI
- Basic UDI-DI
- B-20886333001501 EUDAMED
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020202 BONE MARROW EXPLANT NEEDLES AND KITS 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
Bone Marrow Biopsy Needle by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone marrow biopsy needle, single-use.
- MEDBONE — Medax Unipersonale Srl · Class II
- 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
- BMN J TYPE — H.S. HOSPITAL SERVICE SPA · Class II
- MED-L — Medax Unipersonale Srl · Class II
- 0BIE1410/075 — Biomedical S.r.l. · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (3)
- FDA UDI 289262b4-20f1-479e-95ce-e646d0af0bf2 36 fields · synced Jul 17, 2026
- FDA UDI 26aa320f-fa87-4406-a430-1ad7749dca08 36 fields · synced May 30, 2026
- EUDAMED 9af7a454-e84f-4926-8022-46a298b6aaf3 61 fields · synced Jul 17, 2026