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Device Explorer · FDA GUDID · GMDN 46774

Surgical retractor/retraction system blade, reusable

A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached t

US‑registered devices14,635in commercial distribution
Companies99labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription68%Rx‑only share
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Share of device records

Tedan Surgical Innovations, L.L.C.1,1838%
Vb Spine Llc1,1528%
Koros U.S.A., Inc.1,0477%
Thompson Surgical Instruments, Inc.9597%
Boss Instruments, Ltd., Inc.8686%
Medtronic Sofamor Danek, Inc.6134%
Aspen Surgical Products, Inc.6064%
Rz-Medizintechnik Gmbh5284%

Top labelers

CompanyDevicesShare
Tedan Surgical Innovations, L.L.C.1,1838%
Vb Spine Llc1,1528%
Koros U.S.A., Inc.1,0477%
Thompson Surgical Instruments, Inc.9597%
Boss Instruments, Ltd., Inc.8686%
Medtronic Sofamor Danek, Inc.6134%
Aspen Surgical Products, Inc.6064%
Rz-Medizintechnik Gmbh5284%
Nsi Us4823%
Medfix International, Llc4633%
Life Instrument Corporation4113%
Sontec Instruments, Inc.4043%

Company = labeler of record on GUDID. 99 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LITe TLIFRelianceES2Posterior TLIFAVS NAVIGATORRELIANCE CRELIANCERELIANCE ALRELIANCE LITeO.I.C. TITANIUMLITe PEDICLE BASED RETRACTORPRONASpring Scalp Hook RetractorsSpring HookGrace Medical

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

FDA product codes

CodeNameDevices
GADRetractor4,674
GADRETRACTOR2,710
MDMInstrument, Manual, Surgical, General Use1,476
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,399
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1,123
LXHOrthopedic manual surgical instrument542

GMDN & GCC registration

  • GMDN code 46774 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 68% · 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) · 2,030Width (Millimeter) · 1,100Outer Diameter (Millimeter) · 463Width (Inch) · 438Length (Inch) · 428Depth (Millimeter) · 345

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

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

14,635 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical retractor/retraction system blade, reusable", from 99 companies. The largest labeler is Tedan Surgical Innovations, L.L.C. with 8% of records.

Which FDA product codes apply?

GAD (Retractor), GAD (RETRACTOR), MDM (Instrument, Manual, Surgical, General Use), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT)

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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