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Device Explorer · FDA GUDID · GMDN 58883

Externally-anchored laparoscopic retractor

A non-sterile, intraoperative surgical instrument designed for use during laparoscopic procedures to provide hands-free retraction of lower abdominal, urogenital or pelvic structures. It is inserted into the abdominal cavity through a small dedicated incision

US‑registered devices129in commercial distribution
Companies6labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription23%Rx‑only share
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Share of device records

Flexbar Machine Corporation9876%
Integra Microfrance129%
Avalign Technologies, Inc.119%
Karl Storz Gmbh & Co. Kg32%
Sontec Instruments, Inc.32%
Surgical Innovations Limited22%

Top labelers

CompanyDevicesShare
Flexbar Machine Corporation9876%
Integra Microfrance129%
Avalign Technologies, Inc.119%
Karl Storz Gmbh & Co. Kg32%
Sontec Instruments, Inc.32%
Surgical Innovations Limited22%

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

Brand names on the register (sample)

Pretzelflex - Surgical Retraction Systemn.a.Holders and Positioners - Nathanson HooksMediflex Laparoscopic Instruments - Needle HoldeMediflex Laparoscopic Instruments - Fan RetractoStrongArm Surgical Holders and PositionersMediflex Lapro-Flex Laproscopic InstrumentsSlide-Lock GraspersMicroGripMediflex Laparoscopic Instruments - One-Piece, FMediflex Laparoscopic Instruments - Esophageal DFlexarm Surgical Holders and PositionersMILLINS BLADDER RETRACTORYU-HOLTGREWE MALLEABLE RETRACTOR BLADEMillenniumMILLENNIUM

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

FDA product codes

CodeNameDevices
GADRetractor63
FFORetractor, Self-Retaining24
GCJLaparoscope, general & plastic surgery13
BWNTable And Attachments, Operating-Room12
GCJLaparoscope, General & Plastic Surgery6
GEIElectrosurgical, Cutting & Coagulation & Accessories5

GMDN & GCC registration

  • GMDN code 58883 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 23% · 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

No structured size data on the register.

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

How many externally-anchored laparoscopic retractor products are registered in the US?

129 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Externally-anchored laparoscopic retractor", from 6 companies. The largest labeler is Flexbar Machine Corporation with 76% of records.

Which FDA product codes apply?

GAD (Retractor), FFO (Retractor, Self-Retaining), GCJ (Laparoscope, general & plastic surgery), BWN (Table And Attachments, Operating-Room)

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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