CHATTANOOGA

GUDID 07630039100827

Storz Medical AG

Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system

• Primary Device ID: 07630039100827
• NIH Device Record Key: 8ec2756d-0bdb-4e28-8c76-6c8de888f98e
• Commercial Distribution Discontinuation: 2018-05-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CHATTANOOGA
• Version Model Number: Intelect F-SW - 21095-US
• Company DUNS: 481967776
• Company Name: Storz Medical AG
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630039100827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080028

FDA Product Code

• NBN: Generator, Shock-Wave, For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-16

On-Brand Devices [CHATTANOOGA]

• 07630039101022: CHATTANOOGA Intelect F-SW USA
• 07630039101008: CHATTANOOGA Mobile 2 RPW USA
• 07630039100827: Intelect F-SW - 21095-US
• 07630039100759: Intelect F-SW
• 07630039101312: The device is indicated for extracorporeal shock wave treatment.