FDA.reportPublic FDA data

SURJEX

Primary DI
G383OPERATINGSCISSORSL4
Brand
SURJEX
Company
SURJEX
Model
13-138
Catalog number
13-138
Device description
"OPERATING SCISSOR BL/BL CUR 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
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G383OPERATINGSCISSORSL4PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. 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
00190776407568MillenniumAvalign Technologies, Inc.LRW2026-08-03
00190776422783MillenniumAvalign Technologies, Inc.LRW2026-08-03
00190776422868MillenniumAvalign Technologies, Inc.LRW2026-08-03
00190776407476MillenniumAvalign Technologies, Inc.LRW2026-07-31
00190776422493MillenniumAvalign Technologies, Inc.LRW2026-07-31
00190776422608MillenniumAvalign Technologies, Inc.LRW2026-07-31
00190776422202MillenniumAvalign Technologies, Inc.LRW2026-07-28
00198506092800ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093036ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093326ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093401ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
B382SD9037871020Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9037871030Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9037871090Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9038741050Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9038741100Surgical DirectSurgical Direct, Inc.LRW2026-07-28
00190776405915MillenniumAvalign Technologies, Inc.LRW2026-07-26
00190776422028MillenniumAvalign Technologies, Inc.LRW2026-07-24
00190776421908MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776421922MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776403256MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403300MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403669MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776400392MillenniumAvalign Technologies, Inc.LRW2026-07-17
00840183531546BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531553BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531577BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531614BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531645BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531706BR Surgical, LLCBR Surgical, LLCLRW2026-07-17