FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489882711
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ44034F
Catalog number
DYNJ44034F
Device description
UROLOGY ROBOTIC ADD ON PACK
Published
2021-06-02
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
40193489882712PackageGS15In Commercial Distribution
10193489882711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348988271240193489882712
1019348988271110193489882711

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956550483CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956587359CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956589254CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956589315CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956591240CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956550452CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956555716CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956555938CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956558342CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956561892CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956587434CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956581500CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-21
10198956581586CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-21
10198956583696CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-21
10809160536858HalyardMEDICAL ACTION INDUSTRIES INC.FDE2026-09-18
10198956398467CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-04
10198956487468CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-04
10198956555778CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-04
10198956330221CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956547742CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956564473CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956556805CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-18
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