FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489466102
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ0405275AI
Catalog number
DYNJ0405275AI
Device description
LAP CHOLE PACK-LF
Published
2021-08-27
Public version status
Update
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
40193489466103PackageGS12In Commercial Distribution
10193489466102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348946610340193489466103
1019348946610210193489466102

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888277417205MEDLINEMSG9460MSG94602026-08-03
10888277417212MEDLINEMSG9465MSG94652026-08-03
10888277417229MEDLINEMSG9470MSG94702026-08-03
10888277417236MEDLINEMSG9475MSG94752026-08-03
10888277417243MEDLINEMSG9480MSG94802026-08-03
10888277417250MEDLINEMSG9485MSG94852026-08-03
10888277417267MEDLINEMSG9490MSG94902026-08-03
10888277603516MEDLINEMSG9590MSG95902026-08-03
20197344102898GeminiGEM3120CGEM3120C2024-08-02
20197344102904GeminiGEM3120SCGEM3120SC2024-07-15
10080196184125GeminiGEM3120SGEM3120S2016-10-14
10080196184286MEDLINEGEM3130SGEM3130S2016-10-14
10197344169405MEDLINEMSCSRG9636MSCSRG96362026-07-31
10198459678653MEDLINEURO175806PSURO175806PS2026-07-31
10198459678660MEDLINEURO175808PSURO175808PS2026-07-31
10198459678677MEDLINEURO175806SURO175806S2026-07-31
10198459678684MEDLINEURO175808SURO175808S2026-07-31
10198459678691MEDLINEURO175810SURO175810S2026-07-31
10198459679025MEDLINEURO175810PSURO175810PS2026-07-31
20197344219237MEDLINENON27393NON273932026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956515871CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956524354CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956530805CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956534421CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956538573CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10809160527931HALYARDAVID MEDICAL, INC.FDE2026-07-28
10198956218109CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956360457CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956378339CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956429949CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956460652CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956462991CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956512351CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956516830CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956519619CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956523296CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956528710CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956533332CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
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