FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10195327124915
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKE1844
Catalog number
DYKE1844
Device description
ENDOSCOPY KIT
Published
2022-03-27
Public version status
Update
Distribution status
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
NWUEndoscope introducer kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327124916PackageGS115In Commercial Distribution
10195327124915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532712491640195327124916
1019532712491510195327124915

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
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
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11
10812564036381MedlineSYN3872SYN38722026-03-11
10884389001677Teleflex/Hudson RCI540154012016-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956332102CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956372610CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956388598CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956394643CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956397712CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956448278CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956464322CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956469020CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956475786CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956487369CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956491571CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
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