Consulting Wallah › Device Explorer › Other devices › Fibreoptic retractor handle
Device Explorer · FDA GUDID · GMDN 46773

Fibreoptic retractor handle

A hand-held surgical instrument with an integral fibreoptic bundle intended to accept a retractor blade (not included) to: 1) enable manipulation of the blade during non-self-retaining surgical retraction of tissues; and 2) provide illumination of deep surgica

US‑registered devices318in commercial distribution
Companies17labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription79%Rx‑only share
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Share of device records

Avalign Technologies, Inc.9630%
Stryker Corporation5417%
Hayden Medical, Inc.4514%
Surgical Direct, Inc.299%
Novo Surgical, Inc.268%
Accurate Surgical & Scientific Instruments Corporation155%
Steris Corporation124%
Elmed Incorporated83%

Top labelers

CompanyDevicesShare
Avalign Technologies, Inc.9630%
Stryker Corporation5417%
Hayden Medical, Inc.4514%
Surgical Direct, Inc.299%
Novo Surgical, Inc.268%
Accurate Surgical & Scientific Instruments Corporation155%
Steris Corporation124%
Elmed Incorporated83%
Karl Storz Gmbh & Co. Kg72%
Med Saver, Inc.72%
My Medical Store Llc72%
Kls-Martin L.P.52%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

n.a.RETRACTORNovo SurgicalELMEDASSIHayden MedicalEikon LT Adapt Smoke EvacuationN/AEikonEibergMSI Precision Specialty InstrumentsSurgical DirectMillenniumAmbler SurgicalPILLINGSnowden-Pencer

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

FDA product codes

CodeNameDevices
GADRETRACTOR196
GADRetractor65
FDGRETRACTOR, FIBEROPTIC14
LRCInstrument, Ent Manual Surgical9
FDGRetractor, fiberoptic8
FDGRetractor, Fiberoptic8

GMDN & GCC registration

  • GMDN code 46773 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 79% · 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) · 20Length (Inch) · 6Width (Inch) · 4Length (Feet) · 1

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

How many fibreoptic retractor handle products are registered in the US?

318 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fibreoptic retractor handle", from 17 companies. The largest labeler is Avalign Technologies, Inc. with 30% of records.

Which FDA product codes apply?

GAD (RETRACTOR), GAD (Retractor), FDG (RETRACTOR, FIBEROPTIC), 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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