Consulting Wallah › Device Explorer › Syringes, needles & infusion › General-purpose endoscopic needle, reusable
Device Explorer · FDA GUDID · GMDN 38824

General-purpose endoscopic needle, reusable

A flexible sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape,

US‑registered devices194in commercial distribution
Companies21labelers on GUDID
Single‑use9%of device records
Sterile0%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Karl Storz Gmbh & Co. Kg5930%
Integra Microfrance3418%
Avalign Technologies, Inc.2714%
American Medical Endoscopy, Inc.126%
Steris Corporation95%
Richard Wolf Gmbh84%
Teleflex Incorporated74%
Ambler Surgical Corp.63%

Top labelers

CompanyDevicesShare
Karl Storz Gmbh & Co. Kg5930%
Integra Microfrance3418%
Avalign Technologies, Inc.2714%
American Medical Endoscopy, Inc.126%
Steris Corporation95%
Richard Wolf Gmbh84%
Teleflex Incorporated74%
Ambler Surgical Corp.63%
Mahe Medical Gmbh53%
National Advanced Endoscopy Devices, Inc.53%
Hayden Medical, Inc.53%
Hermann Medizintechnik Gmbh42%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Injection-/puncture needle,w.small LL- connectorInjection-/puncture needle,w.small LL- connectorHermann Medizintechnik GmbHNAmahe medical GmbHn.a.OlympusAEDHayden MedicalUSA Elite SystemUSA EliteStrauss SurgicalAdler Instrument CompanyZOELLNER MICRO EAR NEEDLEMillenniumAvalign

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

FDA product codes

CodeNameDevices
GCJLaparoscope, general & plastic surgery39
GDMNEEDLE, ASPIRATION AND INJECTION, REUSABLE28
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES22
LRCINSTRUMENT, ENT MANUAL SURGICAL14
HRXARTHROSCOPE12
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)10

GMDN & GCC registration

  • GMDN code 38824 · non‑implantable
  • Single‑use 9% · sterile 0% · Rx‑only 85% · 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) · 14Needle Gauge (Gauge) · 13Length (Centimeter) · 11Outer Diameter (Millimeter) · 9

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

How many general-purpose endoscopic needle, reusable products are registered in the US?

194 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-purpose endoscopic needle, reusable", from 21 companies. The largest labeler is Karl Storz Gmbh & Co. Kg with 30% of records.

Which FDA product codes apply?

GCJ (Laparoscope, general & plastic surgery), GDM (NEEDLE, ASPIRATION AND INJECTION, REUSABLE), GEI (ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES), LRC (INSTRUMENT, ENT MANUAL 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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