FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040118747
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701600
Catalog number
5701600
Device description
Basic Pack 6
Published
2020-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDElaparoscopy kit
LROGeneral surgery tray
OGREar, nose, and throat surgical tray
OJHOrthopedic tray
PPFUrinary irrigation kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2
LROGeneral Surgery TrayGeneral, Plastic Surgery2
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1
OJHOrthopedic TrayGeneral, Plastic Surgery1
PPFUrinary Irrigation KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040118747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1030404011874710304040118747

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
Ethylene Oxide

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
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
10304040195472Essentials570582857058282026-09-04
10304040195489Essentials570582957058292026-09-04
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS199160Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS199340Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS199930Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS6160F0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS9487F0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS9509E0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
10198459760846MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-09-25
10198956172715CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956339729CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956374232CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956393288CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956400801CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956424654CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956461086CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956462205CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956486645CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956500730CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956511286CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956512016CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956519275CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956520608CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956524033CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956534308CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956541504CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956541603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956541757CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956541931CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956545151CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956545168CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956548299CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25