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
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05
10304040194307Henry Schein570570757057072026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956382909CARDINAL HEALTHCardinal Health 200, LLCPKE2026-06-01
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