FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040119324
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701660
Catalog number
5701660
Device description
Set-Up Pack 1
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
10304040119324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1030404011932410304040119324

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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160523063HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523070HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523094HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523100HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523124HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523131HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523223HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523230HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523247HalyardAVID MEDICAL, INC.LRO2026-06-09
10197106911266CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10197106983577CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956218611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956332096CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956343139CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956359024CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956362932CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956364783CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956373372CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956373976CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956374119CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956386150CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956387171CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956390430CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956395107CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956402683CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956429666CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956432048CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956433144CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956433984CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956434677CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08