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Bone Marrow Harvest Needle
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref BMHN1104XRef BMHN1303XRef BMHN1304XRef BMHN1104VX
Identity
- Trade Name
- Bone Marrow Harvest Needle EUDAMEDFDA UDIBone Marrow Harvest EUDAMED
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- Bone Marrow Harvest Needle EUDAMEDBone Marrow Harvest Needle 13ga x 2in FDA UDIBone Marrow Harvest Needle 11ga x 4in FDA UDIBone Marrow Harvest Needle 13ga x 3in FDA UDIBone Marrow Harvest Needle 13ga x 4in FDA UDI
- Model / Reference
- BMHN1104X EUDAMEDFDA UDIBMHN1104VX EUDAMEDFDA UDIBMHN1303X EUDAMEDFDA UDIBMHN1304X EUDAMEDFDA UDIBMHN1302X FDA UDI
- Description
- Bone Marrow Harvest Needle 13ga x 2in FDA UDIBone Marrow Harvest Needle 11ga x 4in FDA UDIBone Marrow Harvest Needle 13ga x 3in FDA UDIBone Marrow Harvest Needle 13ga x 4in FDA UDI
Identifiers
- Catalog Number
- BMHN1302X FDA UDIBMHN1104X FDA UDIBMHN1104VX FDA UDIBMHN1303X FDA UDIBMHN1304X FDA UDI
- Primary DI / UDI-DI
- 20886333007640 EUDAMED20886333007671 EUDAMED20886333007695 EUDAMED20886333007664 EUDAMED00886333007684 FDA UDI00886333007646 FDA UDI00886333007660 FDA UDI00886333007677 FDA UDI00886333007691 FDA UDI
- Basic UDI-DI
- B-20886333007640 EUDAMEDB-20886333007671 EUDAMEDB-20886333007695 EUDAMEDB-20886333007664 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
Bone Marrow Harvest Needle 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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- 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 |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (9)
- FDA UDI 622b4aac-614c-49a7-aaef-7df0d5715adc 36 fields · synced Jul 22, 2026
- FDA UDI 9b155eb8-fc0e-429b-929a-f1545b283d10 36 fields · synced May 24, 2026
- FDA UDI 0e1701e9-d7a0-4b4a-a746-ac95575a7fd3 36 fields · synced May 29, 2026
- FDA UDI 3d9f0b06-33ee-4bf2-9ed0-626c44883c26 36 fields · synced May 30, 2026
- FDA UDI b237253c-b741-43b0-9995-e0112481ae9c 36 fields · synced May 30, 2026
- EUDAMED 20eca80d-3506-4a3d-ab45-c55520e21d61 61 fields · synced Jul 10, 2026
- EUDAMED 1f1f5622-62c8-4fdf-a370-f4e4a5ce3983 61 fields · synced Jul 19, 2026
- EUDAMED ff89f253-a449-4068-976f-97879bfe4832 61 fields · synced Jul 21, 2026
- EUDAMED 931182ef-1bd9-4f1b-81d2-2574f0912a95 61 fields · synced Jul 22, 2026