Consulting Wallah › Device Explorer › Syringes, needles & infusion › End-cut biopsy gun handpiece/needle
Device Explorer · FDA GUDID · GMDN 22726

End-cut biopsy gun handpiece/needle

A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consist

US‑registered devices463in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Biopsybell Srl22549%
Argon Medical Devices, Inc.9821%
M.D.L. S.R.L.6514%
Itp Innovative Tomography Products Gmbh215%
Medline Industries, Inc.204%
Medax Srl Unipersonale204%
Inrad123%
Insert Molding Solutions Inc20%

Top labelers

CompanyDevicesShare
Biopsybell Srl22549%
Argon Medical Devices, Inc.9821%
M.D.L. S.R.L.6514%
Itp Innovative Tomography Products Gmbh215%
Medline Industries, Inc.204%
Medax Srl Unipersonale204%
Inrad123%
Insert Molding Solutions Inc20%

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

Brand names on the register (sample)

Semi-automatic Biopsy Needle - BIM16/15iSemi-automatic Biopsy Needle - BIM16/20iSemi-automatic Biopsy Needle - BIM18/15iSemi-automatic Biopsy Needle - BIM18/20iAutomatic Biopsy Needle - BAM 16/15Automatic Biopsy Needle - BAM 16/17Automatic Biopsy Needle - BAM 16/20Automatic Biopsy Needle - BAM 18/15Automatic Biopsy Needle - BAM 18/17Automatic Biopsy Needle - BAM 18/20Semi-automatic Biopsy-Needle BIM 14/15Semi-automatic Biopsy-Needle BIM 14/10Semi-automatic Biopsy-Needle BIM 16/20Semi-automatic Biopsy-Needle BIM 16/15Semi-automatic Biopsy-Needle BIM 16/10Semi-automatic Biopsy-Needle BIM 18/20

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

FDA product codes

CodeNameDevices
KNWInstrument, Biopsy483
FCGBiopsy Needle394
EMEPunch, Biopsy, Surgical16
EMEPUNCH, BIOPSY, SURGICAL10
DYBIntroducer, Catheter3

GMDN & GCC registration

  • GMDN code 22726 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 97% · 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 (Millimeter) · 365Needle Gauge (Gauge) · 365

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

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

463 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "End-cut biopsy gun handpiece/needle", from 8 companies. The largest labeler is Biopsybell Srl with 49% of records.

Which FDA product codes apply?

KNW (Instrument, Biopsy), FCG (Biopsy Needle), EME (Punch, Biopsy, Surgical), EME (PUNCH, BIOPSY, SURGICAL)

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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