FDA.reportPublic FDA data

SURJEX

Primary DI
G383BONEREDUCTIONFORCS3
Brand
SURJEX
Company
SURJEX
Model
WM3240916
Catalog number
WM3240916
Device description
"Bone Reduction Forceps 8"""
Published
2024-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G383BONEREDUCTIONFORCS3PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone holding forcepsA manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. 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
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
G383WM8769920SURJEXWM87699202026-01-31
G383WM8769921SURJEXWM8769921WM87699212026-01-31
G383WM8769922SURJEXWM8769922WM87699222026-01-31
G3831053WM0315CWB5SURJEXWM0315-CWM0315-C2024-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433130MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433147MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433178MillenniumAvalign Technologies, Inc.GEN2026-10-01
B382SD8160490Surgical DirectSurgical Direct, Inc.GEN2026-09-30
00190776432829MillenniumAvalign Technologies, Inc.GEN2026-09-29
00190776432898MillenniumAvalign Technologies, Inc.GEN2026-09-29
B382SD4937851340Surgical DirectSurgical Direct, Inc.GEN2026-09-29
00190776432522MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432553MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432560MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432577MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432744MillenniumAvalign Technologies, Inc.GEN2026-09-28
00724995268985Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995268992Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269005Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269012Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269029Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269036Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269043Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
B35665124160American MedicalsAmerican MedicalsGEN2026-09-25
00724995266752Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-24
00190776431273MillenniumAvalign Technologies, Inc.GEN2026-09-22
00190776432096MillenniumAvalign Technologies, Inc.GEN2026-09-22
04058749037364NAFehling Instruments GmbH & Co. KGGEN2026-09-21
00190776431006MillenniumAvalign Technologies, Inc.GEN2026-09-18
00190776431013MillenniumAvalign Technologies, Inc.GEN2026-09-18
00190776429034MillenniumAvalign Technologies, Inc.GEN2026-09-04
00190776429058MillenniumAvalign Technologies, Inc.GEN2026-09-04
04058749001280NAFehling Instruments GmbH & Co. KGGEN2026-09-04