Bi-Flex ROUS1035ST

GUDID 03700512963585

BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 35cm

Promepla

Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter Ureteral catheter

• Primary Device ID: 03700512963585
• NIH Device Record Key: 6b773378-c9a4-4f13-aceb-2ab4e6b2d5f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bi-Flex
• Version Model Number: ROUS1035ST
• Catalog Number: ROUS1035ST
• 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: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu
• Phone: +37797984243
• Email: customer@rocamed.eu

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700512963585 [Primary]
GS1	03700512973584 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	03700512983583 [Package]; Contains: 03700512973584; Package: Box [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: 6
• Public Version Date: 2019-12-09
• Device Publish Date: 2016-07-19

Devices Manufactured by Promepla

• 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
• 03700512987499 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.30cm, without wire: 2024-01-15
• 03700512987505 - LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.24cm, without wire: 2024-01-15
• 03700512977513 - LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.26cm, without wire: 2024-01-15