FDA.reportPublic FDA data

Henry Schein

Primary DI
H65857018761
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701876
Catalog number
5701876
Device description
PSC Laparotomy Pack
Published
2020-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65857018765PrimaryHIBCC0
H65857018761Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10809160527047HalyardAVID MEDICAL, INC.LRO2026-07-14
10809160527061HalyardAVID MEDICAL, INC.LRO2026-07-14
10809160527085HalyardAVID MEDICAL, INC.LRO2026-07-14
10809160527092HalyardAVID MEDICAL, INC.LRO2026-07-14
10809160527016HalyardAVID MEDICAL, INC.LRO2026-07-13
10809160527023HalyardAVID MEDICAL, INC.LRO2026-07-13
B098AMS14885C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS17983A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS18306A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS192890Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS192920Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS8144C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
10809160526989HalyardAVID MEDICAL, INC.LRO2026-07-10
10809160526996HalyardAVID MEDICAL, INC.LRO2026-07-10
10885632524950SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10885632526978SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10885632526992SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10198956074668CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956119260CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956286719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956386303CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956387959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956420076CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956425996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956457119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956459878CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462151CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956473478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956475427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09