FDA.reportPublic FDA data

Henry Schein

Primary DI
H65810195230
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1019223
Catalog number
1019223
Device description
"Hemostat 537 8"" Straight"
Published
2020-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HRQHEMOSTAT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65810195230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suture scissorsA hand-held surgical instrument used during surgery to cut suture or ligature material, i.e., to divide lengths or remove excessive/unwanted ends. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically metallic and is available in various designs and sizes; the blades may have different shapes, e.g., they can be curved or straight with a hook-like tip to capture the suture/ligature as it is cut. It is not a dedicated ophthalmic device. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055258567Surgical DesignSurgical Design, Inc.HRQ2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.HRQ2026-06-22
05060212051103Crile Artery Forceps, 145mm StraightDTR MEDICAL LIMITEDHRQ2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatDTR MEDICAL LIMITEDHRQ2026-06-10
05060411984639Baby Overholt Artery Forceps Curved, 140mmDTR MEDICAL LIMITEDHRQ2026-06-10
00810212931128SURGIPROSSurgipros, LLCHRQ2026-06-01
00810212931135SURGIPROSSurgipros, LLCHRQ2026-06-01
00810212931142SURGIPROSSurgipros, LLCHRQ2026-06-01
00810212931166SURGIPROSSurgipros, LLCHRQ2026-06-01
00810212931173SURGIPROSSurgipros, LLCHRQ2026-06-01
00810055250684Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250691Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250707Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250714Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259687Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259694Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259700Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259717Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259724Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259731Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00192896117129Meeker Hemostatic ForcepsSONTEC INSTRUMENTS, INC.HRQ2024-03-25
10193489456325Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HRQ2022-08-04
ESAM3800121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3800141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3805121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3805141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3815121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3815141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3826141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3827141STOMA®Storz am Mark GmbHHRQ2020-08-27