JFil® Ureteral Suture Stent JFCS160

GUDID 03700512978350

Comfort Stent 7Fr - 160 mm

Promepla

Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent 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