FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327465514
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ21550T
Catalog number
DYNJ21550T
Device description
C-SECTION PACK-LF
Published
2023-12-21
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
OHMCesarean section tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327465514PackageGS12In Commercial Distribution
10195327465513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532746551440195327465514
1019532746551310195327465513

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
true
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
10198956388345CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956457683CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956477575CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956479654CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956479760CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956483026CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956484924CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485181CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485495CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485532CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956485631CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956488632CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
10198956488786CARDINAL HEALTHCardinal Health 200, LLCOHM2026-05-25
50198956424560CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-24
50198956427455CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-24
50198956337099CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956343434CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956387506CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956402094CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956410181CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956412758CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956414080CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956418002CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956419825CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956420838CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956424324CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-23
50198956366082CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19
50198956373592CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19
50198956376395CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19
50198956390216CARDINAL HEALTHCardinal Health 200, LLCOHM2026-03-19