SilverHawkTM

GUDID 00821684074039

ATHERECTOMY P4028 SILVERHAWK BTK V03

Covidien LP

Mechanical atherectomy system catheter, peripheral Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00821684074039
• NIH Device Record Key: 7346d135-5111-4d17-9e76-51ca0649d110
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SilverHawkTM
• Version Model Number: P4028
• Company DUNS: 968903703
• Company Name: Covidien LP
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place until ready for use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place until ready for use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684074039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061188

FDA Product Code

• MCW: Catheter, peripheral, atherectomy

Sterilization

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

[00821684074039]

Ethylene Oxide

[00821684074039]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26

On-Brand Devices [SilverHawkTM]

• 00821684074169: ATHERECTOMY P4056 SILVERHAWK ATK V03
• 00821684074145: ATHERECTOMY P4055 SILVERHAWK ATK V03
• 00821684074121: ATHERECTOMY P4052 SILVERHAWK ATK V03
• 00821684074107: ATHERECTOMY P4044 SILVERHAWK BTK V03
• 00821684074084: ATHERECTOMY P4034 SILVERHAWK BTK V03
• 00821684074060: ATHERECTOMY P4033 SILVERHAWK BTK V03
• 00821684074046: ATHERECTOMY P4030 SILVERHAWK BTK V03
• 00821684074039: ATHERECTOMY P4028 SILVERHAWK BTK V03