FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10198459189807
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ57623A
Catalog number
DYNJ57623A
Device description
LAP CHOLE PACK
Published
2024-11-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459189808PackageGS13In Commercial Distribution
10198459189807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845918980840198459189808
1019845918980710198459189807

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344216123MEDLINESSBCS21GLSSBCS21GL2026-07-24
10197344219575MEDLINEMDS99905MDS999052026-07-24
10653160391326MEDLINEEBSI1865EBSI18652026-07-24
30193489017742MEDLINE6651CBL22X16651CBL22X12026-07-24
30193489017759MEDLINE6651CBL22X26651CBL22X22026-07-24
30193489017766MEDLINE6651CBL22X36651CBL22X32026-07-24
30193489017773MEDLINE6651CBL22X46651CBL22X42026-07-24
30193489017780MEDLINE6651CBL34X36651CBL34X32026-07-24
30193489017797MEDLINE6651CBL34X46651CBL34X42026-07-24
30193489104893MEDLINEMDT011201XLMDT011201XL2026-07-24
40193489107969MEDLINEMDTISO3AHCAR3MDTISO3AHCAR32026-07-24
40193489120241MEDLINEMDTISO3AHGMDTISO3AHG2026-07-24
40193489120258MEDLINEMDTISO3AHG3XLMDTISO3AHG3XL2026-07-24
50080196247576MEDLINEMDT011205MDT0112052026-07-24
50193489109885MEDLINEMDTISO3AHY3XLMDTISO3AHY3XL2026-07-24
50193489109892MEDLINEMDTISO3AHYCARMDTISO3AHYCAR2026-07-24
10193489987522MEDLINEURO175814TURO175814T2022-05-22
10193489987546MEDLINEURO175818TURO175818T2022-05-22
10193489988505MEDLINEURO175816TURO175816T2022-05-22
00080196311661MEDLINENON241278NON2412782026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS187280Aligned Medical SolutionsAligned Medical SolutionsFDE2026-07-22
10198956388888CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956494701CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956515680CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956516939CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956521681CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956532588CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956458987CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
10198956513099CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
10198956528499CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
10198956531239CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
B098AMS184440Aligned Medical SolutionsAligned Medical SolutionsFDE2026-07-12
10198956395039CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956493599CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956509337CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956512672CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956514416CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956527041CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956503618CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-06
B098AMS15230A0Aligned Medical SolutionsAligned Medical SolutionsFDE2026-06-25
10198956374119CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956387171CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956456778CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956488137CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956495968CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956496279CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956496620CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956339392CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956376748CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956475502CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05