FDA.reportPublic FDA data

SURJEX

Primary DI
G383HEMOSTATHALSTED67
Brand
SURJEX
Company
SURJEX
Model
WM3197445
Catalog number
WM3197445
Device description
"Hemostat, Halsted-Mosquito Curved 5-1/2"""
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
G383HEMOSTATHALSTED67PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clamp manipulation forcepsA hand-held manual surgical instrument with a dedicated, slotted, working end that is designed to accept, grasp, open, apply and remove small types of bulldog/vascular clamps. It is typically made of high-grade stainless steel with jaws at the working end designed to accept the clamp; this gives the surgeon greater range of use of the bulldog clamp into the wound. It has typically a straight design with a slightly curved geometry toward the working end. 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
Expiration date on label
true
No 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
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
00810189450264Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450271Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450288Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450295Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450301Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450318Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450325Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450332Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450349Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450356Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450363Surgical DesignSurgical Design, Inc.GEN2026-05-29
G043201100BEARBear-Ent, LLCGEN2026-04-17
G043201130BEARBear-Ent, LLCGEN2026-04-17
G043201140BEARBear-Ent, LLCGEN2026-04-17
G043201160BEARBear-Ent, LLCGEN2026-04-17
G043201190BEARBear-Ent, LLCGEN2026-04-17
G043201200BEARBear-Ent, LLCGEN2026-04-17
09348811008756INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009029INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009050INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009135INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19