OPTA 4196080S

GUDID 20705032003398

OPTA PRO F5 6X8 80

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 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: 20705032003398
• NIH Device Record Key: a5d4f21f-1d48-45f6-9d11-0dd6e352c192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTA
• Version Model Number: 4196080S
• Catalog Number: 4196080S
• 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 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705032003398 [Primary]

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

On-Brand Devices [OPTA]

• 20705032003817: OPTA PRO F5 9X8 80
• 20705032003800: OPTA PRO F5 9X6 80
• 20705032003794: OPTA PRO F5 9X4 80
• 20705032003787: OPTA PRO F5 9X4 110CM
• 20705032003770: OPTA PRO F5 9X3 80
• 20705032003763: OPTA PRO F5 9X2 80
• 20705032003756: OPTA PRO F5 9X2 110CM
• 20705032003749: OPTA PRO F5 9X1,5 80
• 20705032003732: OPTA PRO F5 9X1 80
• 20705032003725: OPTA PRO F5 9X10 80
• 20705032003718: OPTA PRO F5 8X8 80
• 20705032003701: OPTA PRO F5 8X8 110CM
• 20705032003695: OPTA PRO F5 8X6 80
• 20705032003688: OPTA PRO F5 8X6 110CM
• 20705032003671: OPTA PRO F5 8X4 135CM
• 20705032003664: OPTA PRO F5 8X4 80
• 20705032003657: OPTA PRO F5 8X4 110CM
• 20705032003640: OPTA PRO F5 8X3 80
• 20705032003633: OPTA PRO F5 8X3 110CM
• 20705032003626: OPTA PRO F5 8X2 135CM
• 20705032003619: OPTA PRO F5 8X2 80
• 20705032003602: OPTA PRO F5 8X2 110CM
• 20705032003596: OPTA PRO F5 8X1.5 80
• 20705032003589: OPTA PRO F5 8X1 80
• 20705032003572: OPTA PRO F5 8X10 80
• 20705032003565: OPTA PRO F5 8X10 110 CM
• 20705032003558: OPTA PRO F5 7X8 80
• 20705032003541: OPTA PRO F5 7X8 110CM
• 20705032003534: OPTA PRO F5 7X6 80
• 20705032003527: OPTA PRO F5 7X6 110CM
• 20705032003510: OPTA PRO F5 7X4 135CM
• 20705032003503: OPTA PRO F5 7X4 80
• 20705032003497: OPTA PRO F5 7X4 110CM
• 20705032003480: OPTA PRO F5 7X3 80
• 20705032003473: OPTA PRO F5 7X3 110CM
• 20705032003466: OPTA PRO F5 7X2 135CM
• 20705032003459: OPTA PRO F5 7X2 80
• 20705032003442: OPTA PRO F5 7X2 110CM
• 20705032003435: OPTA PRO F5 7X1.5 80
• 20705032003428: OPTA PRO F5 7X1 80
• 20705032003411: OPTA PRO F5 7X10 80
• 20705032003404: OPTA PRO F5 7X10 110 CM
• 20705032003398: OPTA PRO F5 6X8 80
• 20705032003381: OPTA PRO F5 6X8 110CM
• 20705032003374: OPTA PRO F5 6X6 80
• 20705032003367: OPTA PRO F5 6X6 110CM
• 20705032003350: OPTA PRO F5 6X4 135CM
• 20705032003343: OPTA PRO F5 6X4 80
• 20705032003336: OPTA PRO F5 6X4 110CM
• 20705032003329: OPTA PRO F5 6X3 80