FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489787658
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ905157C
Catalog number
DYNJ905157C
Device description
LAPAROSCOPY
Published
2019-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10193489787658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348978765810193489787658

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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
true
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
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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
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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