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Device Explorer · FDA GUDID · GMDN 37332

Operating room light system

An assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examin

US‑registered devices897in commercial distribution
Companies14labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription31%Rx‑only share
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Share of device records

Dentis Co. ,Ltd38843%
Steris Corporation19722%
Medical Illumination International Inc.17720%
Amtai Medical Equipment, Inc.455%
Avante263%
Burton Medical, Llc233%
Skytron Llc111%
Acem Spa91%

Top labelers

CompanyDevicesShare
Dentis Co. ,Ltd38843%
Steris Corporation19722%
Medical Illumination International Inc.17720%
Amtai Medical Equipment, Inc.455%
Avante263%
Burton Medical, Llc233%
Skytron Llc111%
Acem Spa91%
Stryker Communications Inc.61%
Baxter Medical Systems Gmbh + Co. Kg40%
Advanced Instrumentations, Inc.40%
Klyo Medical Systems Inc.30%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Visum Blade, iSuiteVisum BladeVisumZimmer Surgical LightVidiaPortTL 5000/3000 – Surgical LightAIM 100AIM 200APEXAPEX LEDSYSTEM TWO LEDVu-EVistOR MS LEDVuVu-160VistOR MS

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

FDA product codes

CodeNameDevices
FTDLamp, Surgical414
FSYLight, surgical, ceiling mounted330
FSTLight, Surgical, Fiberoptic177
FSYLight, Surgical, Ceiling Mounted97
FSQLight, surgical, instrument24
FTDLamp, surgical24

GMDN & GCC registration

  • GMDN code 37332 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 31% · OTC 19%
  • 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 operating room light system products are registered in the US?

897 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Operating room light system", from 14 companies. The largest labeler is Dentis Co. ,Ltd with 43% of records.

Which FDA product codes apply?

FTD (Lamp, Surgical), FSY (Light, surgical, ceiling mounted), FST (Light, Surgical, Fiberoptic), FSY (Light, Surgical, Ceiling Mounted)

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?

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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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