FDA.reportPublic FDA data

SURJEX

Primary DI
G383WM8769920
Brand
SURJEX
Company
SURJEX
Model
WM8769920
Device description
"Thorlakson Retractor, 125/175x25mm, 10"""
Published
2026-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G383WM8769920PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
645518882
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G383S1061WM1413S3SURJEXWM1413S3WM1413S32026-05-31
G383S1061WM3240913SURJEXWM3240913WM32409132026-05-31
G383S1061WM3245624S7SURJEXWM3245624WM32456242026-05-31
G383S1061WM8535433SURJEXWM8535433WM85354332026-05-31
G383S1061WM8535437SURJEXWM8535437WM85354372026-05-31
G383WM3241113SURJEXWM3241113WM32411132026-05-31
G3831056WM853543SURJEXWM85354372026-01-31
G3831056WM8535433SURJEXWM85354332026-01-31
G3831056WM8769923SURJEXWM8769923WM87699232026-01-31
G3831056WM8769924SURJEXWM8769924WM87699242026-01-31
G3831056WM8769925SURJEXWM8769925WM87699252026-01-31
G383S105823WM9542161SURJEXWM9542161WM95421612026-01-31
G383WM7778700SURJEXWM7778700WM77787002026-01-31
G383WM7778701SURJEXWM7778701WM77787012026-01-31
G383WM7778702SURJEXWM7778702WM77787022026-01-31
G383WM7778703SURJEXWM7778703WM77787032026-01-31
G383WM8769921SURJEXWM8769921WM87699212026-01-31
G383WM8769922SURJEXWM8769922WM87699222026-01-31
G3831053WM0315CWB5SURJEXWM0315-CWM0315-C2024-06-27
G3831053WM0318S369SURJEXWM0318S3WM0318S32024-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422615MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422691MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422707MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422714MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422776MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422882MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422905MillenniumAvalign Technologies, Inc.GAD2026-08-03
00190776422264MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422288MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422301MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422530MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422547MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422554MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422561MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422578MillenniumAvalign Technologies, Inc.GAD2026-07-31
B382S349571000Surgical DirectSurgical Direct, Inc.GAD2026-07-31
00199150083107Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00199150083879Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-07-30
00810143904659SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904680SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904697SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904703SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904710SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904727SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904918SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904925SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904932SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904949SURGIPROSSurgipros, LLCGAD2026-07-30
00810143904956SURGIPROSSurgipros, LLCGAD2026-07-30
00810143905045SURGIPROSSurgipros, LLCGAD2026-07-30