Mitt Basket MITB1900

GUDID 03700512968184

Ngage-like open mouth basket

Promepla

Biliary/urinary stone retrieval basket, single-use

• Primary Device ID: 03700512968184
• NIH Device Record Key: 5623577a-30c0-4447-a6b3-e1a3fd4e0cb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mitt Basket
• Version Model Number: ROKM1900ST245
• Catalog Number: MITB1900
• Company DUNS: 401020409
• Company Name: Promepla
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700512968184 [Primary]

FDA Product Code

• FFL: Dislodger, Stone, Basket, Ureteral, Metal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-04
• Device Publish Date: 2021-02-24

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