Device Explorer · FDA GUDID · GMDN 60477

Bone biopsy needle

A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone, bone marrow and/or tumour from any bone of the body. It is typically inserted through a bone access cannula under imaging [e.g., fluoroscopic, ultrasonic, comp

US‑registered devices81in commercial distribution
Companies8labelers on GUDID
Single‑use93%of device records
Sterile93%labelled sterile
Prescription62%Rx‑only share
ShareLinkedIn

Share of device records

Merit Medical Systems, Inc.5568%
Apriomed Ab1012%
Captiva Spine, Inc.45%
Möller Medical Gmbh34%
Tarca Llc34%
Varian Medical Systems, Inc.34%
Camber Spine Technologies, Llc22%
Joline Gmbh & Co. Kg11%

Top labelers

CompanyDevicesShare
Merit Medical Systems, Inc.5568%
Apriomed Ab1012%
Captiva Spine, Inc.45%
Möller Medical Gmbh34%
Tarca Llc34%
Varian Medical Systems, Inc.34%
Camber Spine Technologies, Llc22%
Joline Gmbh & Co. Kg11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Bonopty Extended DrillBonopty Biopsy SetBonopty Penetration SetBone biopsy cannulaVertebra Biopsy Device Needle & PlungerMadison™ MiniMadison™Preston™Bedford™Westbrook™Huntington™Kensington™Lee MedicalOmniBone Bone Biopsy Kit with 11 Gauge 158mm lenOmniBone Bone Biopsy Kit with 11 Gauge 108mm lenOmniBone Bone Biopsy Kit with 11 Gauge 68mm leng

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

FDA product codes

CodeNameDevices
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE39
GAANeedle, Aspiration And Injection, Disposable20
GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY8
KNWInstrument, Biopsy6
LXHOrthopedic Manual Surgical Instrument6
HTWBIT, DRILL4

GMDN & GCC registration

  • GMDN code 60477 · non‑implantable
  • Single‑use 93% · sterile 93% · Rx‑only 62% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 20Needle Gauge (Gauge) · 18Outer Diameter (Millimeter) · 2

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

How many bone biopsy needle products are registered in the US?

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone biopsy needle", from 8 companies. The largest labeler is Merit Medical Systems, Inc. with 68% of records.

Which FDA product codes apply?

GAA (NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE), GAA (Needle, Aspiration And Injection, Disposable), GEA (CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY), KNW (Instrument, Biopsy)

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.

How do I get quotes?

Add bone biopsy needle to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Bone biopsy needle

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying bone biopsy needle for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →