BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cm ROUS1235ST

GUDID 03700512983590

Promepla

Ureteral catheter

• Primary Device ID: 03700512983590
• NIH Device Record Key: f814a203-b199-49c0-8caf-e80922801726
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cm
• Version Model Number: ROUS1235ST
• Catalog Number: ROUS1235ST
• 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
• Phone: +37797984232
• Email: customer@rocamed.eu

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700512963592 [Primary]
GS1	03700512973591 [Package]; Contains: 03700512963592; Package: Box label 1 [1 Units]; In Commercial Distribution
GS1	03700512983590 [Package]; Contains: 03700512973591; Package: Box label 2 [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140441

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: 5
• Public Version Date: 2019-12-09
• Device Publish Date: 2016-10-03

Devices Manufactured by Promepla

• 03700512925064 - Irrigation Tube: 2024-11-01
• 03700512925071 - Irrigation Tube: 2024-11-01
• 03700512915263 - Irrigation Tube: 2024-11-01
• 03700512921967 - Y-CLIC ADAPTER: 2024-01-15
• 03700512987451 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire: 2024-01-15
• 03700512987468 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire: 2024-01-15
• 03700512987475 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.26cm, without wire: 2024-01-15
• 03700512987482 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.28cm, without wire: 2024-01-15