OPTA 4198080S

GUDID 20705032003718

OPTA PRO F5 8X8 80

CORDIS CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 20705032003718
• NIH Device Record Key: 2ad84553-fd55-4da0-8165-d06c0ebc69ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTA
• Version Model Number: 4198080S
• Catalog Number: 4198080S
• 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 *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
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damanged
• 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	20705032003718 [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