Stop'n GO Double Balloon Catheter

GUDID 04250203940870

Joline GmbH & Co. KG

Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp

• Primary Device ID: 04250203940870
• NIH Device Record Key: 93b5ab6b-6e58-417c-b08d-e3fe9da6d944
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stop'n GO Double Balloon Catheter
• Version Model Number: US9420
• Company DUNS: 342087108
• Company Name: Joline GmbH & Co. KG
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250203940870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192449

FDA Product Code

• HRX: Arthroscope

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: 2020-08-24
• Device Publish Date: 2020-08-14