FDA.reportPublic FDA data

Henry Schein

Primary DI
H65857031365
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703136
Catalog number
5703136
Device description
Pack Lap Chloe F/ Townsen Memorial Hospital
Published
2022-08-10
Public version status
New
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
PKELaparoscopic Cholecystectomy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKELaparoscopic Cholecystectomy KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65857031365PrimaryHIBCC0
H65857031361Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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
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
10304040166885Henry ScheinHENRY SCHEIN, INC.PKE2023-07-30
00304040166888Henry ScheinHENRY SCHEIN, INC.PKE2023-07-30
H65857031361Henry ScheinHENRY SCHEIN, INC.PKE2022-08-10
M75257029180Stradis Medical, LLC.STRADIS MEDICAL, LLCPKE2022-04-25
M7526902620STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-21
M75257014820STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-17
M7526902530STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-17
10195594582845CARDINAL HEALTHCardinal Health 200, LLCPKE2022-03-11
50195594582843CARDINAL HEALTHCardinal Health 200, LLCPKE2022-03-11
M75257019510STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-03
M752KPX3209A0STRADIS HEALTHCARESTRADIS MEDICAL, LLCPKE2022-03-03
00191072144430ACSAMERICAN CONTRACT SYSTEMS, INC.PKE2021-08-25
00191072120991ACSAMERICAN CONTRACT SYSTEMS, INC.PKE2021-01-05
00191072087409ACSAMERICAN CONTRACT SYSTEMS, INC.PKE2020-09-24
10888439831276CARDINAL HEALTHCardinal Health 200, LLCPKE2020-05-27
50888439831274CARDINAL HEALTHCardinal Health 200, LLCPKE2020-05-27
10888439782387CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
10888439795868CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
50888439782385CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
50888439795866CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-31
10888439793598CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-20
50888439793596CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-20
10888439678697CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-12
50888439678695CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-12
10888439766929CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-04
50888439766927CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-04
10888439771541CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-02
50888439771549CARDINAL HEALTHCardinal Health 200, LLCPKE2020-03-02
10888439629576CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-26
50888439629574CARDINAL HEALTHCardinal Health 200, LLCPKE2020-02-26