LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.28cm, without wire ROJS9728ST228

GUDID 03700512987567

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

• Primary Device ID: 03700512987567
• NIH Device Record Key: d5a2303c-754c-416b-99b0-1d83f1fcc22c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.28cm, without wire
• Version Model Number: 09-0135
• Catalog Number: ROJS9728ST228
• 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	03700512967569 [Primary]
GS1	03700512977568 [Package]; Contains: 03700512967569; Package: box [1 Units]; In Commercial Distribution
GS1	03700512987567 [Package]; Contains: 03700512977568; 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: 2018-08-20

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