POWERFLEX 4400503X

GUDID 20705032059319

POWERFLEXPRO 5MM3CM 135

CORDIS CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 20705032059319
• NIH Device Record Key: bdf99ba5-384f-4e64-a4f7-725104ba6026
• Commercial Distribution Discontinuation: 2019-09-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: POWERFLEX
• Version Model Number: 4400503X
• Catalog Number: 4400503X
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705032059319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112797

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: 6
• Public Version Date: 2019-09-13
• 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