FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327663484
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ40136B
Catalog number
DYNJ40136B
Device description
CYSTO PACK
Published
2024-07-29
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
40195327663484PackageGS14In Commercial Distribution
10195327663483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532766348440195327663484
1019532766348310195327663483

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
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