FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40198459037215
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ49101I
Catalog number
DYNJ49101I
Device description
LAP CHOLE PACK
Published
2024-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
40198459037215PackageGS16In Commercial Distribution
10198459037214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845903721540198459037215
1019845903721410198459037214

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956428348CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956438163CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
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10198956455306CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956466340CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956470781CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956477216CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956484436CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
10198956485891CARDINAL HEALTHCardinal Health 200, LLCFDE2026-05-25
50198956285987CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-24
50198956316537CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956344547CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956370959CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956379013CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956397390CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956415902CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956422276CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956321920CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956325782CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956334043CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956340044CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956340051CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956343311CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956362756CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956365481CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956384475CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956256765CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956295610CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956346053CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956352917CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16