FDA.reportPublic FDA data

SURJEX

Primary DI
G3831056WM8769923
Brand
SURJEX
Company
SURJEX
Model
WM8769923
Catalog number
WM8769923
Device description
"Thorlakson Retractor with Handle,170x40mm 13"""
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
G3831056WM8769923PrimaryHIBCC0

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
No natural rubber latex
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
G3831056WM8769924SURJEXWM8769924WM87699242026-01-31
G3831056WM8769925SURJEXWM8769925WM87699252026-01-31
G383S105823WM9542161SURJEXWM9542161WM95421612026-01-31
G383WM7778700SURJEXWM7778700WM77787002026-01-31
G383WM7778701SURJEXWM7778701WM77787012026-01-31
G383WM7778702SURJEXWM7778702WM77787022026-01-31
G383WM7778703SURJEXWM7778703WM77787032026-01-31
G383WM8769920SURJEXWM87699202026-01-31
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
00810168190471NAPACIFIC INSTRUMENTS, INC.GAD2026-07-09
00888937033663ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00888937033670ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00841536148473ThompsonThompson Surgical Instruments, Inc.GAD2026-07-08
00850083275341Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275570Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275969Intrace USAPILOTIS TECH LLCGAD2026-07-03
B8035202680ORTHOMEDORTHO-MED, INC.GAD2026-06-26
00190776421748MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421809MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421816MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421830MillenniumAvalign Technologies, Inc.GAD2026-06-24
00192896123540Green RetractorSONTEC INSTRUMENTS, INC.GAD2026-06-24
00810220800447Adler Instrument CompanyAdler, Inc.GAD2026-06-24
00190776421649MillenniumAvalign Technologies, Inc.GAD2026-06-23
00190776421670MillenniumAvalign Technologies, Inc.GAD2026-06-23
00810158211292PRINCETONPrinceton Medical Group, Inc.GAD2026-06-23
00348783011456Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
00348783011463Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
008401944956533P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956603P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956843P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
05060212055323Silicone Bands 2.16mm x 110mm dia x 3DTR MEDICAL LIMITEDGAD2026-06-10
00198506091339ELMED INCORPORATEDELMED INCORPORATEDGAD2026-06-09
00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04