SilverHawk™

GUDID 00643169968455

ATHERECTOMY P4028 DS SILVERHAWK BTK UNI

MEDTRONIC, INC.

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

• Primary Device ID: 00643169968455
• NIH Device Record Key: 7d815837-27ac-4d52-aae1-5f9e4419a93e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SilverHawk™
• Version Model Number: P4028
• 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

Device Dimensions

• Length: 132 Centimeter
• Length: 132 Centimeter
• Length: 132 Centimeter
• Length: 132 Centimeter
• Length: 132 Centimeter
• Length: 132 Centimeter
• Length: 132 Centimeter
• Length: 132 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169968455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170191

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-22

On-Brand Devices [SilverHawk™]

• 00643169968479: ATHERECTOMY P4044 EXL SILVERHAWK BTK UNI
• 00643169968462: ATHERECTOMY P4030 SS+ SILVERHAWK BTK UNI
• 00643169968455: ATHERECTOMY P4028 DS SILVERHAWK BTK UNI
• 00643169968448: ATHERECTOMY P4056 MS-M SILVERHAWK ATK UN
• 00643169968431: ATHERECTOMY P4055 LX-M SILVERHAWK ATK UN