SAVVY 435404X

GUDID 20705032006535

PTA SAVVY 4.00 X 4CM 150CM

CORDIS CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 20705032006535
• NIH Device Record Key: e076f2be-dc25-46c7-90ef-e6f013df5590
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAVVY
• Version Model Number: 435404X
• Catalog Number: 435404X
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705032006535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971010

FDA Product Code

• LIT: Catheter, angioplasty, peripheral, transluminal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-01

On-Brand Devices [SAVVY]

• 20705032006825: PTA SAVVY 80CM 6X6
• 20705032006818: PTA SAVVY 120CM 6X6
• 20705032006801: PTA SAVVY 80CM 6X4
• 20705032006795: PTA SAVVY 120CM 6X4
• 20705032006788: PTA SAVVY 80CM 6X2
• 20705032006771: PTA SAVVY 120CM 6X2
• 20705032006764: PTA SAVVY 6.00X10CM 80CM
• 20705032006757: PTA SAVVY 6.00X10CM 120CM
• 20705032006740: PTA SAVVY 120CM 5.5X6
• 20705032006733: PTA SAVVY 80CM 5.5X4
• 20705032006726: PTA SAVVY 120CM 5.5X4
• 20705032006719: PTA SAVVY 80CM 5.5X2
• 20705032006702: PTA SAVVY 120CM 5.5X2
• 20705032006696: PTA SAVVY 80CM 5X6
• 20705032006689: PTA SAVVY 120CM 5X6
• 20705032006672: PTA SAVVY 80CM 5X4
• 20705032006665: PTA SAVVY 120CM 5X4
• 20705032006658: PTA SAVVY 80CM 5X2
• 20705032006641: PTA SAVVY 120CM 5X2
• 20705032006634: PTA SAVVY 5.00X10CM 80CM
• 20705032006627: PTA SAVVY 5.00X10CM 120CM
• 20705032006610: PTA SAVVY 80CM 4.5X6
• 20705032006603: PTA SAVVY 120CM 4.5X6
• 20705032006597: PTA SAVVY 80CM 4.5X4
• 20705032006580: PTA SAVVY 120CM 4.5X4
• 20705032006573: PTA SAVVY 80CM 4.5X2
• 20705032006566: PTA SAVVY 120CM 4.5X2
• 20705032006559: PTA SAVVY SMALL VESSEL 4X6
• 20705032006542: PTA SAVVY SMALL VESSEL 4X6
• 20705032006535: PTA SAVVY 4.00 X 4CM 150CM
• 20705032006528: PTA SAVVY 4.0MM/4.0CM 80CM
• 20705032006511: PTA SAVVY 4.00 X 4CM 120CM
• 20705032006504: PTA SAVVY 4.0MM/3.0CM 120CM
• 20705032006498: PTA SAVVY 4.00 X 2CM 150CM
• 20705032006481: PTA SAVVY 4.0MM X 2.0CM 80CM
• 20705032006474: PTA SAVVY 4.00 X 2CM 120CM
• 20705032006467: PTA SAVVY 4X10CM 150CM
• 20705032006450: PTA SAVVY SMALL VESSEL 4X10
• 20705032006443: PTA SAVVY SMALL VESSEL 4X10
• 20705032006436: PTA SAVVY SMALL VESSEL 3.5X6
• 20705032006429: PTA SAVVY SMALL VESSEL 3.5X6
• 20705032006412: PTA SAVVY 3.50 X 4CM 150CM
• 20705032006405: PTA SAVVY 3.5MM X 4.0CM 80CM
• 20705032006399: PTA SAVVY 3.50 X 4CM 120CM
• 20705032006382: PTA SAVVY 3.5MM/3.0CM 120CM
• 20705032006375: PTA SAVVY 3.50 X 2CM 150CM
• 20705032006368: PTA SAVVY 3.5MM X 2.0CM 80CM
• 20705032006351: PTA SAVVY 3.50 X 2CM 120CM
• 20705032006337: PTA SAVVY SMALL VESSEL 3.5X10
• 20705032006320: PTA SAVVY SMALL VESSEL 3.5X10