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Device Explorer · FDA GUDID · GMDN 65349

Open surgical site internal light

An electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typi

US‑registered devices68in commercial distribution
Companies11labelers on GUDID
Single‑use87%of device records
Sterile87%labelled sterile
Prescription59%Rx‑only share
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Share of device records

Lumitex, Inc.3450%
Nico Corporation812%
Wuxi Emsrun Technology Co., Ltd.57%
Boss Instruments, Ltd., Inc.57%
Sunoptic Technologies Llc46%
Swan Medical Sl.46%
Steris Corporation34%
Alphatec Spine, Inc.23%

Top labelers

CompanyDevicesShare
Lumitex, Inc.3450%
Nico Corporation812%
Wuxi Emsrun Technology Co., Ltd.57%
Boss Instruments, Ltd., Inc.57%
Sunoptic Technologies Llc46%
Swan Medical Sl.46%
Steris Corporation34%
Alphatec Spine, Inc.23%
Teleflex Incorporated11%
Medtronic Sofamor Danek, Inc.11%
Vivo Surgical Private Limited11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Lightning X Products,IncEMSRUNPILLINGBOSS InstrumentsNICO MyriadNICO Myriad-LXThompson Surgical LitePath Integrated D 13mmLumitex Surgical Malleable IlluminatorLumitex Surgical Tube IlluminatorMedtronic Surgical Illuminator - BladeMedtronic Surgical Illuminator - TubeLumitex Surgical IlluminatorL&K Biomed BluEX Surgical Illuminator4WEB Medical OA51S Surgical IlluminatorLattus Spine Surgical IlluminatorPrecision Spine TLIF Bifurcated Surgical Illumin

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

FDA product codes

CodeNameDevices
FDGRetractor, Fiberoptic71
FDGRetractor, fiberoptic6
FSTLight, Surgical, Fiberoptic6
KYTLight, Examination, Medical, Battery Powered5
FTDLamp, Surgical4
FSQLight, Surgical, Instrument4

GMDN & GCC registration

  • GMDN code 65349 · non‑implantable
  • Single‑use 87% · sterile 87% · Rx‑only 59% · OTC 6%
  • 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) · 1

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

No closely related category with 50+ devices.

How many open surgical site internal light products are registered in the US?

68 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Open surgical site internal light", from 11 companies. The largest labeler is Lumitex, Inc. with 50% of records.

Which FDA product codes apply?

FDG (Retractor, Fiberoptic), FDG (Retractor, fiberoptic), FST (Light, Surgical, Fiberoptic), KYT (Light, Examination, Medical, Battery Powered)

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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