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Device Explorer · FDA GUDID · GMDN 48036

Surgical instrument fibreoptic light

A sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a

US‑registered devices62in commercial distribution
Companies6labelers on GUDID
Single‑use71%of device records
Sterile71%labelled sterile
Prescription50%Rx‑only share
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Share of device records

Lumitex, Inc.4776%
Teleflex Incorporated58%
Invuity, Inc.46%
I-Tek Medical, Inc.35%
Gulf Fiberoptics, Inc.23%
Stryker Corporation12%

Top labelers

CompanyDevicesShare
Lumitex, Inc.4776%
Teleflex Incorporated58%
Invuity, Inc.46%
I-Tek Medical, Inc.35%
Gulf Fiberoptics, Inc.23%
Stryker Corporation12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LITe DECOMPRESSIONPILLINGFiber Optic IlluminatorFiber Optic Light CablePhotonGuideEigr™ WaveguideLife Spine Surgical IlluminatorSpinal Elements 26mm Port IlluminatorSpinal Elements 22mm Port IlluminatorChoice Spine Surgical IlluminatorSpineart 2.5mm Universal Reusable Light CableIn'Tech Medical SAS 40mm Surgical IlluminatorPinnacle Spine Products 4mm ACMI Reusable Light Pinnacle Spine Products 4mm ACMI Bifurcated ReusTriton Medical Port IlluminatorMedacta International Surgical Illuminator

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

FDA product codes

CodeNameDevices
FDGRetractor, Fiberoptic54
FSZLight, Surgical, Carrier4
FDGRETRACTOR, FIBEROPTIC3
EQHSOURCE, CARRIER, FIBEROPTIC LIGHT2
FSTLIGHT, SURGICAL, FIBEROPTIC1
FSTLight, Surgical, Fiberoptic1

GMDN & GCC registration

  • GMDN code 48036 · non‑implantable
  • Single‑use 71% · sterile 71% · Rx‑only 50% · 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 (Inch) · 4Depth (Inch) · 4Width (Inch) · 4Length (Millimeter) · 1

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

How many surgical instrument fibreoptic light products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical instrument fibreoptic light", from 6 companies. The largest labeler is Lumitex, Inc. with 76% of records.

Which FDA product codes apply?

FDG (Retractor, Fiberoptic), FSZ (Light, Surgical, Carrier), FDG (RETRACTOR, FIBEROPTIC), EQH (SOURCE, CARRIER, FIBEROPTIC LIGHT)

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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