FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40889942424918
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ901862B
Catalog number
DYNJ901862B
Device description
LOU URETEROSCOPY
Published
2016-11-07
Public version status
Update
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
FCMTray, catheterization, sterile urethral, with or without catheter (kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40889942424918PackageGS14In Commercial Distribution
10889942424917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088994242491840889942424918
1088994242491710889942424917

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)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
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
false
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
05708932778268SpeediCath Flex SetColoplast A/SFCM2026-02-05
50192253069547DoverCardinal Health 200, LLCFCM2026-01-20
50192253068533DoverCardinal Health 200, LLCFCM2026-01-16
50192253068540DoverCardinal Health 200, LLCFCM2026-01-16
50192253068557DoverCardinal Health 200, LLCFCM2026-01-16
50192253068564DoverCardinal Health 200, LLCFCM2026-01-16
50192253068571DoverCardinal Health 200, LLCFCM2026-01-16
50192253068588DoverCardinal Health 200, LLCFCM2026-01-16
50192253068595DoverCardinal Health 200, LLCFCM2026-01-16
50192253068618DoverCardinal Health 200, LLCFCM2026-01-16
50192253068663DoverCardinal Health 200, LLCFCM2026-01-16
50192253068700DoverCardinal Health 200, LLCFCM2026-01-16
50192253067956DoverCardinal Health 200, LLCFCM2026-01-15
50192253067994DoverCardinal Health 200, LLCFCM2026-01-15
50192253068007DoverCardinal Health 200, LLCFCM2026-01-15
50192253070857DoverCardinal Health 200, LLCFCM2026-01-15
50192253027752DoverCardinal Health 200, LLCFCM2025-12-10
50192253028834DoverCardinal Health 200, LLCFCM2025-12-10
50192253028841DoverCardinal Health 200, LLCFCM2025-12-10
50192253030172DoverCardinal Health 200, LLCFCM2025-10-17
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40704411019580AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019597AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019603AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019610AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019627AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
40704411019634AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01