Consulting Wallah › Device Explorer › Syringes, needles & infusion › End-cut biopsy gun needle
Device Explorer · FDA GUDID · GMDN 64327

End-cut biopsy gun needle

An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue

US‑registered devices118in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Remington Medical, Inc.6051%
Sterylab Srl2521%
M.D.L. S.R.L.1916%
Argon Medical Devices, Inc.1311%
Xaga Surgical Ab11%

Top labelers

CompanyDevicesShare
Remington Medical, Inc.6051%
Sterylab Srl2521%
M.D.L. S.R.L.1916%
Argon Medical Devices, Inc.1311%
Xaga Surgical Ab11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Forsvall biopsy needleUltraCore™ Biopsy NeedleRemington Medical, Inc. Automatic Cutting NeedleFastCutSFastCutEFastCutPPalium NeedleFAST-CUTFAST-CUT BFAST-CUT PLUS

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

FDA product codes

CodeNameDevices
KNWInstrument, biopsy60
KNWInstrument, Biopsy49
MJGDevice, Percutaneous, Biopsy38
FCGBiopsy Needle26
DWONeedle, Biopsy, Cardiovascular18
JAKSystem, X-Ray, Tomography, Computed2

GMDN & GCC registration

  • GMDN code 64327 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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) · 60Needle Gauge (Gauge) · 38Length (Millimeter) · 37

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

How many end-cut biopsy gun needle products are registered in the US?

118 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "End-cut biopsy gun needle", from 5 companies. The largest labeler is Remington Medical, Inc. with 51% of records.

Which FDA product codes apply?

KNW (Instrument, biopsy), KNW (Instrument, Biopsy), MJG (Device, Percutaneous, Biopsy), FCG (Biopsy Needle)

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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