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Device Explorer · FDA GUDID · GMDN 45181

Surgical retraction system, reusable

A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surge

US‑registered devices7,585in commercial distribution
Companies54labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription55%Rx‑only share
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Share of device records

Thompson Surgical Instruments, Inc.2,93539%
Alphatec Spine, Inc.1,04414%
Integra Lifesciences Corporation89612%
Nuvasive, Inc.5537%
Medtronic Sofamor Danek, Inc.3234%
Life Spine, Inc.3154%
Spineart Sa1872%
Flexbar Machine Corporation1762%

Top labelers

CompanyDevicesShare
Thompson Surgical Instruments, Inc.2,93539%
Alphatec Spine, Inc.1,04414%
Integra Lifesciences Corporation89612%
Nuvasive, Inc.5537%
Medtronic Sofamor Danek, Inc.3234%
Life Spine, Inc.3154%
Spineart Sa1872%
Flexbar Machine Corporation1762%
Landanger1592%
Avalign Technologies, Inc.1542%
Elmed Incorporated1402%
Steris Corporation1182%

Company = labeler of record on GUDID. 54 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Grace MedicalSL-Lateral Muscle Blade 50 mm short teeth, anodiSL Lateral Muscle Blade 45 mm short teeth, oliveSL Lateral Muscle Blade 40 mm short teeth, dark SL Lateral Muscle Blade 35 mm short teeth, anodiSL Lateral Muscle Blade 30 mm short teeth, anodiSL Tissue Blade 75 mm blunt anodised dark orangeSL Tissue Blade 70 mm blunt anodised yellowSL Tissue Blade 65 mm blunt anodised titaniumSL Tissue Blade 60 mm blunt anodised dark goldSL Tissue Blade 45 mm blunt anodised olive-greenSL Tissue Blade 55 mm blunt anodised blackSL Tissue Blade 50 mm anodised dark violetSL Tissue Blade 40 mm blunt anodised dark redSL Tissue Blade 35mm blunt anodised dark blueSL Tissue Blade 30 mm blunt silver, anodised nat

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

FDA product codes

CodeNameDevices
GADRetractor3,740
GADRETRACTOR2,679
FFORETRACTOR, SELF-RETAINING998
FGNRETRACTOR, NON-SELF-RETAINING889
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT843
DWSInstruments, Surgical, Cardiovascular282

GMDN & GCC registration

  • GMDN code 45181 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 55% · 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) · 106Length (Inch) · 74Outer Diameter (Millimeter) · 62Height (Millimeter) · 43Width (Inch) · 31Width (Millimeter) · 20

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

How many surgical retraction system, reusable products are registered in the US?

7,585 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical retraction system, reusable", from 54 companies. The largest labeler is Thompson Surgical Instruments, Inc. with 39% of records.

Which FDA product codes apply?

GAD (Retractor), GAD (RETRACTOR), FFO (RETRACTOR, SELF-RETAINING), FGN (RETRACTOR, NON-SELF-RETAINING)

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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