HawkOne™

GUDID 00643169728783

ATHERECTOMY H1-S US HAWKONE V01

Covidien LP

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00643169728783
• NIH Device Record Key: b034322a-663b-41a3-8adb-1e93bc85a4b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HawkOne™
• Version Model Number: H1-S
• 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: false
• 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

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French

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
• 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	00643169728783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161361

FDA Product Code

• MCW: Catheter, peripheral, atherectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-29

On-Brand Devices [HawkOne™]

• 00643169968554: ATHERECTOMY H1-14550 CUTTER DRIVER UNI
• 00643169968509: ATHERECTOMY H1-LX HAWKONE 7F EXT TIP US
• 00643169968486: ATHERECTOMY H1-LS HAWKONE 7F STD TIP US
• 00643169968356: ATHERECTOMY H1-S HAWKONE 6F US
• 00643169968332: ATHERECTOMY H1-M HAWKONE 6F US
• 00643169792319: ATHERECTOMY H1-S US HAWKONE V02
• 00643169792302: ATHERECTOMY H1-M US HAWKONE V02
• 00643169777644: ATHERECTOMY H1-14550 CUTTER DRIVER V03
• 00643169728783: ATHERECTOMY H1-S US HAWKONE V01
• 00643169728769: ATHERECTOMY H1-M US HAWKONE V01
• 00763000202699: ATHERECTOMY H1-14550 CUTTER DRIVER US