Silhouette® Pediatric Ureteral Stent with Urowire® Guidewire

GUDID 00607915113117

Designed for patients 2 years and older for Temporary indwelling ureteral catheter to assist in urine drainage

APPLIED MEDICAL RESOURCES CORPORATION

Polymeric ureteral stent

• Primary Device ID: 00607915113117
• NIH Device Record Key: 4e1f1b98-e8ea-4870-a6e2-7e27eaffc44a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silhouette® Pediatric Ureteral Stent with Urowire® Guidewire
• Version Model Number: B3883
• Company DUNS: 187129135
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607915113117 [Primary]

FDA Product Code

• KNY: Accessories, Catheter, G-U

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-07-16

On-Brand Devices [Silhouette® Pediatric Ureteral Stent with Urowire® Guidewire]

• 00607915113131: Designed for patients 2 years and older for Temporary indwelling ureteral catheter to assist in
• 00607915113124: Designed for patients 2 years and older for Temporary indwelling ureteral catheter to assist in
• 00607915113117: Designed for patients 2 years and older for Temporary indwelling ureteral catheter to assist in