FDA.reportPublic FDA data

SURJEX

Primary DI
G383S1091WM96734332
Brand
SURJEX
Company
SURJEX
Model
WM9673433
Catalog number
WM9673433
Device description
CUSTOM MADE SHOULDER TRAY
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G383S1091WM96734332PrimaryHIBCC0

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
G383S1084WM85354372SURJEXWM8535437WM85354372026-10-31
G383S1084WM98733224SURJEXWM9873322WM98733222026-10-31
G383S1084WM98733234SURJEXWM9873323WM98733232026-10-31
G383S1084WM9873329SURJEXWM9873329WM98733292026-10-31
G383S1085WM3357218SURJEXWM3357218WM33572182026-10-31
G383S1085WM7786614SURJEXWM7786614WM77866142026-10-31
G383S1085WM77866155SURJEXWM7786615WM77866152026-10-31
G383S1090WM9673433SURJEXWM9673433WM96734332026-10-31
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842078100226HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100233HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100240HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100332IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100349XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078101896Jones UnionEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078102770IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078103098IO FiX TrioEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078107935XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078108253APEXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109359IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109373CarpalFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110003CompressX2EXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110102AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110133AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112182Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112199Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112205Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112250Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114025Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114636Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114643Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078115305Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078115770Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116661Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116678Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116685Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078117200KinematX TotalEXTREMITY MEDICAL, LLCFSM2026-11-02