FDA.reportPublic FDA data

SURJEX

Primary DI
G383S1084WM85354372
Brand
SURJEX
Company
SURJEX
Model
WM8535437
Catalog number
WM8535437
Device description
FEMORAL NECK ELEVATOR LENGTH--13"HANDLE LENGTH--9" BLADE WIDE---25MM
Published
2026-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G383S1084WM85354372PrimaryHIBCC0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
645518882
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G383S1084816TC95SURJEX8-16TC8-16TC2026-10-31
G383S1084WM853543327SURJEXWM8535433WM85354332026-10-31
G383S1084WM98733224SURJEXWM9873322WM98733222026-10-31
G383S1084WM98733234SURJEXWM9873323WM98733232026-10-31
G383S1084WM9873329SURJEXWM9873329WM98733292026-10-31
G383S1085WM3357218SURJEXWM3357218WM33572182026-10-31
G383S1085WM7786614SURJEXWM7786614WM77866142026-10-31
G383S1085WM77866155SURJEXWM7786615WM77866152026-10-31
G383S1090WM9673433SURJEXWM9673433WM96734332026-10-31
G383S1091WM96734332SURJEXWM9673433WM96734332026-10-31
G383S1092WM0202S3SURJEXWM0202S3WM0202S32026-10-31
G383S1092WM0205S3SURJEXWM0205S3WM0205S32026-10-31
G383S1092WM0220S3SURJEXWM0220S3WM0220S32026-10-31
G383S1092WM0405S3SURJEXWM0405S3WM0405S32026-10-31
G383S1092WM0413S3SURJEXWM0413S3WM0413S32026-10-31
G383S1092WM0418S3M4SURJEXWM0418S3WM0418S32026-10-31
G383S1092WM0914S3N7SURJEXWM0914S3WM0914S32026-10-31
G383S1092WM0948S3SURJEXWM0948S3WM0948S32026-10-31
G383S1092WM0958S3SURJEXWM0958S3WM0958S32026-10-31
G383S1092WM1025615SURJEXWM1025615WM10256152026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850090726218Intrace USAPILOTIS TECH LLCGEG2026-10-31
00850090726225Intrace USAPILOTIS TECH LLCGEG2026-10-31
B382SD9147091150Surgical DirectSurgical Direct, Inc.GEG2026-10-28
04250337117919Elevator, smallJoimax GmbHGEG2026-10-27
04250337119623NiTi Nerve Hook, superelasticJoimax GmbHGEG2026-10-27
04250337122043ElevatorJoimax GmbHGEG2026-10-27
00190776435738MillenniumAvalign Technologies, Inc.GEG2026-10-21
00190776435486MillenniumAvalign Technologies, Inc.GEG2026-10-20
00190776435141MillenniumAvalign Technologies, Inc.GEG2026-10-16
00190776435202MillenniumAvalign Technologies, Inc.GEG2026-10-16
00724995268053Snowden-PencerSTERIS Deutschland GmbHGEG2026-10-15
00724995268060Snowden-PencerSTERIS Deutschland GmbHGEG2026-10-15
B382SD914700200Surgical DirectSurgical Direct, Inc.GEG2026-10-09
B382SD922682100Surgical DirectSurgical Direct, Inc.GEG2026-10-09
B382SD939422110Surgical DirectSurgical Direct, Inc.GEG2026-10-09
B382SD907019950Surgical DirectSurgical Direct, Inc.GEG2026-10-08
00190776433567MillenniumAvalign Technologies, Inc.GEG2026-10-06
00190776433574MillenniumAvalign Technologies, Inc.GEG2026-10-06
00190776433253MillenniumAvalign Technologies, Inc.GEG2026-10-05
00190776433260MillenniumAvalign Technologies, Inc.GEG2026-10-05
00190776433277MillenniumAvalign Technologies, Inc.GEG2026-10-05
B382SD9071741090Surgical DirectSurgical Direct, Inc.GEG2026-09-29
B382SD9207121110Surgical DirectSurgical Direct, Inc.GEG2026-09-29
00724995267995Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268008Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268015Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268022Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268039Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268046Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00190776431600MillenniumAvalign Technologies, Inc.GEG2026-09-22