Consulting Wallah › Device Explorer › Syringes, needles & infusion › Bone marrow biopsy needle, single-use
Device Explorer · FDA GUDID · GMDN 46350

Bone marrow biopsy needle, single-use

A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or post

US‑registered devices385in commercial distribution
Companies22labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Teleflex Incorporated7519%
Medax Srl Unipersonale7419%
Argon Medical Devices, Inc.5514%
Ranfac Corp.328%
M.D.L. S.R.L.328%
Bard Peripheral Vascular, Inc.236%
H.S. Hospital Service Spa236%
Möller Medical Gmbh185%

Top labelers

CompanyDevicesShare
Teleflex Incorporated7519%
Medax Srl Unipersonale7419%
Argon Medical Devices, Inc.5514%
Ranfac Corp.328%
M.D.L. S.R.L.328%
Bard Peripheral Vascular, Inc.236%
H.S. Hospital Service Spa236%
Möller Medical Gmbh185%
Carefusion 2200, Inc144%
Remington Medical, Inc.62%
Customed Inc62%
Tarca Llc41%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Bone marrow biopsy systemBone marrow aspiration biopsyBone Marrow BiopsyGeneral Biopsy TrayT-Lok™ Economy Bone Marrow TrayBone Marrow TrayT-Lok™ Bone Marrow TrayBone Marrow Biopsy TrayBone Marrow Harvest NeedleCustom Bone Marrow TrayT-Lok™ Bone Marrow Biopsy NeedleOsty-Core™Osty-Core™ Bone Biopsy NeedlePediatric Bone Marrow NeedleBone Marrow Biopsy NeedleBone Marrow Aspiration Needle

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KNWInstrument, Biopsy221
KNWINSTRUMENT, BIOPSY77
DWONeedle, Biopsy, Cardiovascular71
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE31
OJTAspiration Tray22
FCGBiopsy needle22

GMDN & GCC registration

  • GMDN code 46350 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 98% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Needle Gauge (Gauge) · 205Length (Millimeter) · 118Length (Inch) · 63Length (Centimeter) · 20

Use these as the dimensions to specify in a tender line.

How many bone marrow biopsy needle, single-use products are registered in the US?

385 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone marrow biopsy needle, single-use", from 22 companies. The largest labeler is Teleflex Incorporated with 19% of records.

Which FDA product codes apply?

KNW (Instrument, Biopsy), KNW (INSTRUMENT, BIOPSY), DWO (Needle, Biopsy, Cardiovascular), GAA (NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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