Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Endoscopic light source unit, line-powered
Device Explorer · FDA GUDID · GMDN 35158

Endoscopic light source unit, line-powered

A mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have addit

US‑registered devices288in commercial distribution
Companies31labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Depuy Spine, Llc12844%
Ilo Electronic Gmbh197%
Olympus Medical Systems Corp.166%
Sopro155%
Karl Storz Gmbh & Co. Kg145%
Long Island Tech103%
Medisono, Llc103%
Richard Wolf Gmbh83%

Top labelers

CompanyDevicesShare
Depuy Spine, Llc12844%
Ilo Electronic Gmbh197%
Olympus Medical Systems Corp.166%
Sopro155%
Karl Storz Gmbh & Co. Kg145%
Long Island Tech103%
Medisono, Llc103%
Richard Wolf Gmbh83%
Schölly Fiberoptic Gmbh72%
Atmos Medizintechnik Gmbh & Co. Kg62%
Stryker Corporation52%
Zhuhai Dipu Medical Technology Co., Ltd.52%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

L12L11L10L9000PRECISIONDPM, Endoscopic Fluorescence Camera System, 3D DPM, Endoscopic Fluorescence Camera SystemDPM, 3D Endoscopic Fluorescence Camera SystemNear-Infrared LED Light SourceLED Light SourceSonoScapeN/ALIGHT SOURCEPENTAXEVIS EXERA III XENON LIGHT SOURCEVISERA ELITE III LED LIGHT SOURCE

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

FDA product codes

CodeNameDevices
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY129
NTNLed Light Source29
GCTLight source, endoscope, xenon arc21
GCJLaparoscope, General & Plastic Surgery17
FDSGastroscope And Accessories, Flexible/Rigid17
GCTLight Source, Endoscope, Xenon Arc17

GMDN & GCC registration

  • GMDN code 35158 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 82% · 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

No structured size data on the register.

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

How many endoscopic light source unit, line-powered products are registered in the US?

288 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscopic light source unit, line-powered", from 31 companies. The largest labeler is Depuy Spine, Llc with 44% of records.

Which FDA product codes apply?

GZT (RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY), NTN (Led Light Source), GCT (Light source, endoscope, xenon arc), GCJ (Laparoscope, General & Plastic Surgery)

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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