SAVVY 435554L

GUDID 20705032006726

PTA SAVVY 120CM 5.5X4

CORDIS CORPORATION

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 20705032006726
• NIH Device Record Key: b97fd5e6-29cd-4859-bb6c-b08e9f8426d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAVVY
• Version Model Number: 435554L
• Catalog Number: 435554L
• 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 *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
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dark, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705032006726 [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