GUDID 00763000402433

ATHERECTOMY FG02550 CUTTERDRIVER

MEDTRONIC, INC.

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00763000402433
• NIH Device Record Key: e963461b-908e-42fc-8b82-a0c950fc85b0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: FG02550
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000402433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212027

FDA Product Code

• MCW: Catheter, peripheral, atherectomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-04
• Device Publish Date: 2021-09-26

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