FDA.reportPublic FDA data

Henry Schein

Primary DI
H65857029435
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702943
Catalog number
5702943
Device description
Pack Angio F/ NY Surgical
Published
2022-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65857029435PrimaryHIBCC0
H65857029431Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
012430880
Device count
4
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00884450486627Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-18
00884450486641Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-17
00884450486849Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-17
10198956439603CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956499560CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956511620CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956526068CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956526839CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956527928CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956529335CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10809160527283HalyardAVID MEDICAL, INC.OEQ2026-07-16
10809160527290HalyardAVID MEDICAL, INC.OEQ2026-07-16
00884450487341Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-10
10198956307308CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956349834CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956368163CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956470897CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956483651CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956485143CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956491588CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956499959CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956504035CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956517752CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956521650CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956524750CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956525580CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956525832CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956526174CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527249CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527645CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09