FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327133567
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKE1847
Catalog number
DYKE1847
Device description
ENDO KIT
Published
2022-06-05
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
40195327133567PackageGS110In Commercial Distribution
10195327133566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532713356740195327133567
1019532713356610195327133566

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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
true
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
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
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956364349CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956408739CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956428775CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956474673CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956482272CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956482562CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956489684CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956496309CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956498037CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956498600CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956499164CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956367630CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956379855CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956431669CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956469976CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956482036CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956485655CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956492837CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956496590CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956499454CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956482791CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-03
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