POWERFLEX EXTREME 4155040M

GUDID 20705032001677

Extreme 5 x 4 120cm

CORDIS CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 20705032001677
• NIH Device Record Key: e095a91f-ccb6-4d31-b5fd-374d51ed606e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWERFLEX EXTREME
• Version Model Number: 4155040M
• Catalog Number: 4155040M
• Company DUNS: 806136177
• Company Name: CORDIS CORPORATION
• 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	10705032001670 [Primary]
GS1	20705032001677 [Package]; Contains: 10705032001670; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032737

FDA Product Code

• DQY: Catheter, percutaneous

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: 2024-03-04
• Device Publish Date: 2024-02-23

On-Brand Devices [POWERFLEX EXTREME]

• 20705032002025: Extreme 9 x 4 120cm
• 20705032001820: Extreme 7 x 4 120cm
• 20705032001745: Extreme 6 x 4 120cm
• 20705032001714: Extreme 6 x 2 120cm
• 20705032001677: Extreme 5 x 4 120cm
• 20705032001646: Extreme 5 x 2 120cm