Identity
- Trade Name
- Bone Marrow Harvest Needle FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- Bone Marrow Harvest Needle 11ga x 4in FDA UDI
- Model / Reference
- FS-BMHN1104X FDA UDI
- Description
- Bone Marrow Harvest Needle 11ga x 4in FDA UDI
Identifiers
- Catalog Number
- FS-BMHN1104X FDA UDI
- Primary DI / UDI-DI
- B183FSBMHN1104X0 FDA UDI
- 510(k) Number
- K141850 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Bone marrow biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 Flospine — Class II — FDA UDI — listed in 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
Cleared under the same submission
K141850 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Flospine
Sources (1)
- FDA UDI 1a10b197-a669-460e-b5e6-ac1e73c0cfe5 37 fields · synced Jun 1, 2026