FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942528172
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
UROT1022A
Catalog number
UROT1022A
Device description
TRAY URETHRAL VINYL CATHETER
Published
2021-08-20
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
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
40889942528173PackageGS120In Commercial Distribution
10889942528172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088994252817340889942528173
1088994252817210889942528172

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
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704945990RUSCHTELEFLEX INCORPORATEDFCM2026-05-12
10192253069549DoverCardinal Health 200, LLCFCM2026-01-20
10192253068535DoverCardinal Health 200, LLCFCM2026-01-16
10192253068542DoverCardinal Health 200, LLCFCM2026-01-16
10192253068559DoverCardinal Health 200, LLCFCM2026-01-16
10192253068566DoverCardinal Health 200, LLCFCM2026-01-16
10192253068573DoverCardinal Health 200, LLCFCM2026-01-16
10192253068580DoverCardinal Health 200, LLCFCM2026-01-16
10192253068597DoverCardinal Health 200, LLCFCM2026-01-16
10192253068610DoverCardinal Health 200, LLCFCM2026-01-16
10192253068665DoverCardinal Health 200, LLCFCM2026-01-16
10192253068702DoverCardinal Health 200, LLCFCM2026-01-16
10192253067958DoverCardinal Health 200, LLCFCM2026-01-15
10192253067996DoverCardinal Health 200, LLCFCM2026-01-15
10192253068009DoverCardinal Health 200, LLCFCM2026-01-15
10192253070859DoverCardinal Health 200, LLCFCM2026-01-15
10192253027754DoverCardinal Health 200, LLCFCM2025-12-10
10192253028836DoverCardinal Health 200, LLCFCM2025-12-10
10192253028843DoverCardinal Health 200, LLCFCM2025-12-10
10192253030174DoverCardinal Health 200, LLCFCM2025-10-17
10192253028935DoverCardinal Health 200, LLCFCM2025-09-16
10192253028942DoverCardinal Health 200, LLCFCM2025-09-16
10704411019541AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019558AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019565AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019572AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019589AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019596AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019602AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01
10704411019619AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.FCM2025-07-01