FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40193489975704
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKE1734B
Catalog number
DYKE1734B
Device description
ENDO KIT
Published
2021-11-19
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489975704PackageGS120In Commercial Distribution
10193489975703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348997570440193489975704
1019348997570310193489975703

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
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
00080196515939CURADCUR9224CUR92242026-07-06
10197344012039HUDSON RCIHUD1743HUD17432026-07-06
10197344216956MEDLINEDYND17403QDYND17403Q2026-07-06
10884389161562MEDLINEMNK0005MNK00052026-07-06
00197344111513CURADCURSSCH300CURSSCH3002026-07-03
40080196772026MEDLINEMDT011201LMDT011201L2026-07-03
40884389110493MEDLINEDYND75026DYND750262026-07-03
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956397361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956488465CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956491922CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956492059CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956492073CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956494794CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956496262CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956497214CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956502888CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956509443CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956513891CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525016CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525160CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525207CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525566CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525641CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525726CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956525894CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956526648CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956526815CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10198956527430CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-06
10809160526484HalyardAVID MEDICAL, INC.OEZ2026-07-06
10809160526514HalyardAVID MEDICAL, INC.OEZ2026-07-06
00884450423790Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-03
00884450079973Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101537Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101568Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09