FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327279951
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKE1892
Catalog number
DYKE1892
Device description
ENDO KIT
Published
2023-06-13
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327279951PackageGS125In Commercial Distribution
10195327279950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532727995140195327279951
1019532727995010195327279950

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
10195327465865Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-12-21
10195327537302Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-12-21
10195327544317Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-12-21
10195327482886Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-10-15
10195327495756Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-09-17
10195327479107Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-08-20
10195327480264Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-08-20
10195327481292Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-08-20
10195327443726Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-07-29
10195327449223Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-07-09
10195327454401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-07-09
10195327442521Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-25
10195327272562Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327275440Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327279950Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327280055Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-13
10195327265892Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-08
10195327266073Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-08
10195327266356Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-08
10195327418144Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327420420Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327420895Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327423360Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-06-04
10195327407650Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-28
10195327402808Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327406097Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327406103Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327406110Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327407148Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14
10195327407728Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-05-14