Endopyelotomy Stent with SL-6® Hydrophilic Coating

GUDID 00607915111946

Temporary indwelling ureteral catheter to assist in urine draining.

APPLIED MEDICAL RESOURCES CORPORATION

Polymeric ureteral stent

• Primary Device ID: 00607915111946
• NIH Device Record Key: f6229328-6a9f-42a1-8b97-f90b56bbe7fd
• Commercial Distribution Discontinuation: 2019-06-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Endopyelotomy Stent with SL-6® Hydrophilic Coating
• Version Model Number: B3304
• Company DUNS: 187129135
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• 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: 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: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com

Device Dimensions

• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Length: 24 Centimeter
• Catheter Gauge: 10 French
• Catheter Gauge: 7 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607915111946 [Primary]

FDA Product Code

• FAD: Stent, Ureteral

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-29
• Device Publish Date: 2015-06-19

On-Brand Devices [Endopyelotomy Stent with SL-6® Hydrophilic Coating]

• 00607915111960: Temporary indwelling ureteral catheter to assist in urine draining
• 00607915111953: Temporary indwelling ureteral catheter to assist in urine draining
• 00607915111946: Temporary indwelling ureteral catheter to assist in urine draining.
• 00607915111939: Temporary indwelling ureteral catheter to assist in urine draining.
• 00607915111922: Temporary indwelling ureteral catheter to assist in urine draining
• 00607915111915: Temporary indwelling ureteral catheter to assist in urine draining