InstantCath 9676

GUDID 20610075104455

Pre-lubricated Urethral Intermittent Catheter

HOLLISTER INCORPORATED

Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter

• Primary Device ID: 20610075104455
• NIH Device Record Key: 0e0f4014-42c0-48ca-b478-b4511135cc43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InstantCath
• Version Model Number: 9676
• Catalog Number: 9676
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 30
• 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: false
• 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(800)323-4060
• Email: CS@Hollister.com
• Phone: +1(800)323-4060
• Email: CS@Hollister.com
• Phone: +1(800)323-4060
• Email: CS@Hollister.com
• Phone: +1(800)323-4060
• Email: CS@Hollister.com
• Phone: +1(800)323-4060
• Email: CS@Hollister.com

Device Dimensions

• Catheter Gauge: 14 French
• Catheter Length: 20 Centimeter
• Catheter Gauge: 14 French
• Catheter Length: 20 Centimeter
• Catheter Gauge: 14 French
• Catheter Length: 20 Centimeter
• Catheter Gauge: 14 French
• Catheter Length: 20 Centimeter
• Catheter Gauge: 14 French
• Catheter Length: 20 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075067244 [Unit of Use]
GS1	00610075104451 [Primary]
GS1	20610075104455 [Package]; Contains: 00610075104451; Package: Case [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011552

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: 2024-07-17
• Device Publish Date: 2024-07-09

On-Brand Devices [InstantCath]

• 20610075104479: Pre-lubricated Urethral Intermittent Catheter
• 20610075104455: Pre-lubricated Urethral Intermittent Catheter
• 20610075104448: Pre-lubricated Urethral Intermittent Catheter
• 20610075104431: Pre-lubricated Urethral Intermittent Catheter
• 25390166097587: Pre-lubricated Urethral Intermittent Catheter
• 20610075104417: Pre-lubricated Urethral Intermittent Catheter
• 20610075104400: Pre-lubricated Urethral Intermittent Catheter
• 20610075104394: Pre-lubricated Urethral Intermittent Catheter