RocaJJ Soft Stent - Ø 4,8 Fr - Length 26cm

GUDID 03700512983439

Promepla

Polymeric ureteral stent

• Primary Device ID: 03700512983439
• NIH Device Record Key: f570d2e9-abcc-4ac2-ac09-d7067e557efd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RocaJJ Soft Stent - Ø 4,8 Fr - Length 26cm
• Version Model Number: ROJS9526ST
• 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

Customer Support Contacts

• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu
• Phone: +37797984232
• Email: customer@rocamed.eu

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700512973430 [Primary]
GS1	03700512983439 [Package]; Contains: 03700512973430; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173734

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: 2
• Public Version Date: 2024-01-15
• Device Publish Date: 2018-05-08

On-Brand Devices [RocaJJ Soft Stent - Ø 4,8 Fr - Length 26cm ]

• 03700512983644: ROJG9526ST
• 03700512983439: ROJS9526ST