FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10888277548626
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKE1148
Catalog number
DYKE1148
Device description
ENDO KIT
Published
2016-11-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWRKit, catheter, foley (excludes hiv testing)
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWRKit, catheter, foley (excludes hiv testing)
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277548626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827754862610888277548626

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA general-purpose collection of various sterile surgical instruments, dressings, and materials intended to be used to assist a range of surgical procedures across multiple clinical specialities. It does not contain pharmaceuticals. This is a reusable 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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
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10195327537302Medline Industries, Inc.MEDLINE INDUSTRIES, INC.NWU2023-12-21
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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
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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
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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
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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