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Device Explorer · FDA GUDID · GMDN 47431

Radial surgical retractor

A sterile surgical device intended to be inserted across a surgical incision to separate the margins of the incision to create a conduit to the underlying organs/tissues during hand-assisted minimally-invasive and open surgery. It consists of an external and i

US‑registered devices63in commercial distribution
Companies9labelers on GUDID
Single‑use97%of device records
Sterile97%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Applied Medical Resources Corporation3454%
Medline Industries, Inc.711%
Covidien Lp610%
V L V Associates (Inc)58%
Alpha Ai Co.,Ltd.46%
Ethicon Endo-Surgery, Llc35%
Prescient Surgical, Inc.23%
Coopersurgical, Inc.12%

Top labelers

CompanyDevicesShare
Applied Medical Resources Corporation3454%
Medline Industries, Inc.711%
Covidien Lp610%
V L V Associates (Inc)58%
Alpha Ai Co.,Ltd.46%
Ethicon Endo-Surgery, Llc35%
Prescient Surgical, Inc.23%
Coopersurgical, Inc.12%
Thompson Surgical Instruments, Inc.12%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Lone Star Reusable Retractor RingCleanCision Wound Retraction and Protection SystCleanCision™ Wound Retraction and Protection SysThompsonAlexis® Lighted Wound Protector-RetractorAlexis® Orthopaedic ProtectorAlexis ® Orthopaedic ProtectorAlexis O Wound Protector-RetractorAlexis Wound Protector-RetractorAlexis Laparoscopic SystemAlexis ® O C-Section Protector - RetractorAlexis ® O C-Section Protector-RetractorEZ Access™SurgiSleeveMIGS Kit 1Medline

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

FDA product codes

CodeNameDevices
KGWRing (Wound Protector), Drape Retention, Internal39
GCJLaparoscope, general & plastic surgery9
GADRETRACTOR6
FTFIlluminator, Non-Remote5
KNAInstrument, Manual, Specialized Obstetric-Gynecologic4
LXHOrthopedic Manual Surgical Instrument4

GMDN & GCC registration

  • GMDN code 47431 · non‑implantable
  • Single‑use 97% · sterile 97% · Rx‑only 98% · 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

Outer Diameter (Centimeter) · 2

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

How many radial surgical retractor products are registered in the US?

63 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radial surgical retractor", from 9 companies. The largest labeler is Applied Medical Resources Corporation with 54% of records.

Which FDA product codes apply?

KGW (Ring (Wound Protector), Drape Retention, Internal), GCJ (Laparoscope, general & plastic surgery), GAD (RETRACTOR), FTF (Illuminator, Non-Remote)

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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