POWERFLEX 4400810X

GUDID 20705032059883

POWERFLEXPRO 8MM10CM 135

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: 20705032059883
• NIH Device Record Key: fb80e3c0-e85c-4ffe-b4a8-9432c638ed3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWERFLEX
• Version Model Number: 4400810X
• Catalog Number: 4400810X
• 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 dry
• 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 dry
• 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	20705032059883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121442

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-01

On-Brand Devices [POWERFLEX]

• 20705032072806: POWERFLEXPRO 12MM6CM 135
• 20705032060193: POWERFLEXPRO 12MM6CM 80
• 20705032060186: POWERFLEXPRO 12MM4CM 135
• 20705032060179: POWERFLEXPRO 12MM4CM 80
• 20705032060162: POWERFLEXPRO 12MM3CM 135
• 20705032060155: POWERFLEXPRO 12MM3CM 80
• 20705032060148: POWERFLEXPRO 12MM2CM 135
• 20705032060131: POWERFLEXPRO 12MM2CM 80
• 20705032060124: POWERFLEXPRO 10MM10CM 135
• 20705032060117: POWERFLEXPRO 10MM10CM 80
• 20705032060100: POWERFLEXPRO 10MM8CM 135
• 20705032060094: POWERFLEXPRO 10MM8CM 80
• 20705032060087: POWERFLEXPRO 10MM6CM 135
• 20705032060070: POWERFLEXPRO 10MM6CM 80
• 20705032060063: POWERFLEXPRO 10MM4CM 135
• 20705032060056: POWERFLEXPRO 10MM4CM 80
• 20705032060049: POWERFLEXPRO 10MM3CM 135
• 20705032060032: POWERFLEXPRO 10MM3CM 80
• 20705032060025: POWERFLEXPRO 10MM2CM 135
• 20705032060018: POWERFLEXPRO 10MM2CM 80
• 20705032060001: POWERFLEXPRO 9MM10CM 135
• 20705032059999: POWERFLEXPRO 9MM10CM 80
• 20705032059982: POWERFLEXPRO 9MM8CM 135
• 20705032059975: POWERFLEXPRO 9MM8CM 80
• 20705032059968: POWERFLEXPRO 9MM6CM 135
• 20705032059951: POWERFLEXPRO 9MM6CM 80
• 20705032059944: POWERFLEXPRO 9MM4CM 135
• 20705032059937: POWERFLEXPRO 9MM4CM 80
• 20705032059920: POWERFLEXPRO 9MM3CM 135
• 20705032059913: POWERFLEXPRO 9MM3CM 80
• 20705032059906: POWERFLEXPRO 9MM2CM 135
• 20705032059890: POWERFLEXPRO 9MM2CM 80
• 20705032059883: POWERFLEXPRO 8MM10CM 135
• 20705032059876: POWERFLEXPRO 8MM10CM 80
• 20705032059869: POWERFLEXPRO 8MM8CM 135
• 20705032059852: POWERFLEXPRO 8MM8CM 80
• 20705032059845: POWERFLEXPRO 8MM6CM 135
• 20705032059838: POWERFLEXPRO 8MM6CM 80
• 20705032059821: POWERFLEXPRO 8MM4CM 135
• 20705032059814: POWERFLEXPRO 8MM4CM 80
• 20705032059807: POWERFLEXPRO 8MM3CM 135
• 20705032059791: POWERFLEXPRO 8MM3CM 80
• 20705032059784: POWERFLEXPRO 8MM2CM 135
• 20705032059777: POWERFLEXPRO 8MM2CM 80
• 20705032059760: POWERFLEXPRO 7MM10CM 135
• 20705032059753: POWERFLEXPRO 7MM10CM 80
• 20705032059746: POWERFLEXPRO 7MM8CM 135
• 20705032059739: POWERFLEXPRO 7MM8CM 80
• 20705032059722: POWERFLEXPRO 7MM6CM 135
• 20705032059715: POWERFLEXPRO 7MM6CM 80