JFil® Ureteral Suture Stent JFCS160

GUDID 03700512978350

Comfort Stent 7Fr - 160 mm

Promepla

Polymeric ureteral stent

• Primary Device ID: 03700512978350
• NIH Device Record Key: c89114b2-aab3-4f25-bb6a-2adc1a08fc92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JFil® Ureteral Suture Stent
• Version Model Number: ROJV5716ST
• Catalog Number: JFCS160
• Company DUNS: 401020409
• Company Name: Promepla
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700512968351 [Primary]
GS1	03700512978350 [Package]; Contains: 03700512968351; Package: Box [1 Units]; In Commercial Distribution
GS1	03700512988359 [Package]; Package: Box [4 Units]; In Commercial Distribution

FDA Product Code

• FAD: Stent, Ureteral

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: 2022-04-14
• Device Publish Date: 2022-04-06

On-Brand Devices [JFil® Ureteral Suture Stent]

• 03700512978350: Comfort Stent 7Fr - 160 mm
• 03700512978343: Comfort Stent 7Fr - 80mm