FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
40198459470234
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKE1723B
Catalog number
DYKE1723B
Device description
ENDO KIT
Published
2025-08-11
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
OFFCentral venous catheter tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFFCentral Venous Catheter TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459470234PackageGS125In Commercial Distribution
10198459470233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845947023440198459470234
1019845947023310198459470233

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
20809160515218MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFF2026-03-06
20809160515003Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2026-03-04
20809160515027Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2026-03-04
50198956373165CARDINAL HEALTHCardinal Health 200, LLCOFF2026-03-03
50198956326369CARDINAL HEALTHCardinal Health 200, LLCOFF2026-03-02
50198956390964CARDINAL HEALTHCardinal Health 200, LLCOFF2026-03-02
50198956326277CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-13
20809160512255MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFF2026-02-11
50198956344592CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-09
50198956350661CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-09
50198956351880CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-09
50198956325058CARDINAL HEALTHCardinal Health 200, LLCOFF2026-01-15
00191072241597ACSAMERICAN CONTRACT SYSTEMS, INC.OFF2026-01-14
00191072241399ACSAMERICAN CONTRACT SYSTEMS, INC.OFF2026-01-06
00191072241405ACSAMERICAN CONTRACT SYSTEMS, INC.OFF2026-01-06
50198956302943CARDINAL HEALTHCardinal Health 200, LLCOFF2025-12-26
20809160506650Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2025-12-17
50198956285864CARDINAL HEALTHCardinal Health 200, LLCOFF2025-12-11
50198956263688CARDINAL HEALTHCardinal Health 200, LLCOFF2025-12-10
20809160495183Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2025-09-24
50198956070729CARDINAL HEALTHCardinal Health 200, LLCOFF2025-08-28
20809160492755MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFF2025-08-25
40198459326685MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459440589MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459454968MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459469474MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459469481MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459472696MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459481551MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459406370MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-11