LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.26cm, without wire ROJS9526ST228

GUDID 03700512987475

Promepla

Polymeric ureteral stent

• Primary Device ID: 03700512987475
• NIH Device Record Key: 6711a8dd-368c-4aa9-b8b1-4ab544596408
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.26cm, without wire
• Version Model Number: 09-0126
• Catalog Number: ROJS9526ST228
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700512967477 [Primary]
GS1	03700512977476 [Package]; Contains: 03700512967477; Package: box [1 Units]; In Commercial Distribution
GS1	03700512987475 [Package]; Contains: 03700512977476; 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

• 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
• 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