FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489905534
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ20135M
Catalog number
DYNJ20135M
Device description
C-SECTION PACK
Published
2021-09-01
Public version status
Update
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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489905534PackageGS13In Commercial Distribution
10193489905533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348990553440193489905534
1019348990553310193489905533

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
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
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
10198956450684CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956519022CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956557574CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956568136CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956572041CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956580848CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956586000CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956589186CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956271418CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956576902CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956580596CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956584587CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956584600CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956587090CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956450417CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-21
10809160538364HalyardMEDICAL ACTION INDUSTRIES INC.OHM2026-09-21
10198956514461CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956556676CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956562288CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956570221CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956570412CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956499720CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956537279CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956537965CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956563636CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956524262CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-18
10198956556416CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-18
10198956554627CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-17
10198956510944CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956516243CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31