TruCath SC1216S

GUDID 50850025153350

Male Straight 12FR SOFT

HR PHARMACEUTICALS INC.

Urine-sampling urethral catheter

• Primary Device ID: 50850025153350
• NIH Device Record Key: 69ed1203-e3a3-4e09-bf98-ec17645a2596
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruCath
• Version Model Number: SC1216S
• Catalog Number: SC1216S
• Company DUNS: 828918164
• Company Name: HR PHARMACEUTICALS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com
• Phone: +1(717)252-1110
• Email: sbenser@hrpharma.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025153355 [Primary]
GS1	10850025153352 [Package]; Contains: 00850025153355; Package: Box [30 Units]; In Commercial Distribution
GS1	50850025153350 [Package]; Contains: 10850025153352; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111405

FDA Product Code

• GBM: CATHETER, URETHRAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-16
• Device Publish Date: 2023-05-08

On-Brand Devices [TruCath]

• 10851809002798: TruCath intermittent straight pediatric catheter
• 10851809002781: TruCath intermittent straight pediatric catheter
• 50851809002772: TruCath intermittent straight male catheter
• 10851809002767: TruCath intermittent straight male catheter
• 10851809002750: TruCath intermittent straight male catheter
• 10851809002743: TruCath intermittent straight male catheter
• 10851809002736: TruCath intermittent straight male catheter
• 10851809002729: TruCath intermittent straight male catheter
• 50851809002710: TruCath Intermittent Catheter Insertion Kit
• 50851809002703: TruCath Intermittent Catheter Insertion Kit
• 50851809002604: TruCath Closed System catheter
• 50851809002581: TruCath Closed System catheter
• 50851809002574: TruCath Closed System catheter
• 50851809002567: TruCath Closed System catheter
• 50851809002550: TruCath Closed System Catheter Kit
• 50851809002543: TruCath Closed System Catheter Kit
• 50851809002536: TruCath Closed System Catheter Kit
• 50851809002529: TruCath Closed System Catheter Kit
• 10851809002323: TruCath intermittent Coude catheter
• 50851809002291: TruCath intermittent Coude catheter
• 50851809002284: TruCath intermittent Coude catheter
• 10851809002279: TruCath intermittent Coude catheter
• 50851809002260: TruCath intermittent Coude catheter
• 10851809002255: TruCath intermittent straight female catheter
• 50851809002246: TruCath intermittent straight female catheter (no connector)
• 10851809002231: TruCath intermittent straight female catheter
• 50851809002222: TruCath intermittent straight female catheter
• 50851809002215: TruCath intermittent straight female catheter
• 50851809002208: TruCath intermittent straight female catheter
• 50850025153138: TruCath Night Drainage Bag 2000mL
• 50850025153121: TruCath Premium Leg Bag 1000mL
• 50850025153114: TruCath Premium Leg Bag 500mL
• 10850025153390: Hydrophilic coude catheter 12 fr
• 10850025153383: Hydrophilic coude catheter 14 fr
• 10850025153376: Male Straight 16FR SOFT
• 50850025153367: Male Straight 14FR SOFT
• 50850025153350: Male Straight 12FR SOFT
• 50850025153343: Pediatric Straight 6FR
• 10850025153338: Male Hydro 14FR SOFT
• 10850025153321: Male Hydro 12FR SOFT
• 50850025153312: Male Hydro Coude 16FR SOFT
• 10850025153307: Pediatric Hydro Coude 10FR
• 10850025153291: Pediatric Hydro Coude 8FR
• 10850025153284: Pediatric Coude 8FR
• 10850058254231: TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 24 Fr 5 ml, 2-Way
• 10850058254224: TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 22 Fr 5 ml, 2-Way
• 10850058254217: TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 20 Fr 5 ml, 2-Way
• 50850058254208: TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 18 Fr 5 ml, 2-Way
• 10850058254194: TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 16 Fr 5 ml, 2-Way
• 50850058254185: TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 14 Fr 5 ml, 2-Way