FDA.reportPublic FDA data

SURJEX

Primary DI
G383HEMOSTATROCHESTERQ4
Brand
SURJEX
Company
SURJEX
Model
WM3197470, WM3197455
Catalog number
WM3197470, WM3197455
Device description
" Hemostat Rochester Pean Curved 18cm 7-1/4""Hemostat Rochester Ochsner 1:2 Curved 18cm 7"""
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
G383HEMOSTATROCHESTERQ4PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
Contains 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
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
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275495Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275600Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275723Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275846Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275938Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275976Intrace USAPILOTIS TECH LLCGEN2026-07-03
00860015282088Intrace USAPILOTIS TECH LLCGEN2026-07-03
00198506091476ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-09
00810189451506Surgical DesignSurgical Design, Inc.GEN2026-06-06
00198506091230ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-03
G383S1061WM1413S3SURJEXSURJEXGEN2026-05-31
G383S1061WM3240913SURJEXSURJEXGEN2026-05-31
G383WM3241113SURJEXSURJEXGEN2026-05-31
00810055250929Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250936Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250943Surgical DesignSurgical Design, Inc.GEN2026-05-29