ATTAIN HYBRID™ Guide Wire

GUDID 00643169452428

GUIDE WIRE GWR419578 98CM GLOBAL CE

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00643169452428
• NIH Device Record Key: 91730315-7fed-4a45-8623-c4cd5708d8a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATTAIN HYBRID™ Guide Wire
• Version Model Number: GWR419578
• 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: 98 Centimeter
• Length: 98 Centimeter
• Length: 98 Centimeter
• Length: 98 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169452428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143316

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-03

On-Brand Devices [ATTAIN HYBRID™ Guide Wire]

• 00643169452701: GUIDE WIRE GWR419378 98CM GLOBAL CE
• 00643169452459: GUIDE WIRE GWR419388 108CM GLOBAL CE
• 00643169452442: GUIDE WIRE GWR419478 98CM GLOBAL CE
• 00643169452435: GUIDE WIRE GWR419488 108CM GLOBAL CE
• 00643169452428: GUIDE WIRE GWR419578 98CM GLOBAL CE
• 00643169452411: GUIDE WIRE GWR419588 108CM GLOBAL CE
• 00643169452404: GUIDE WIRE GWR419678 98CM GLOBAL CE
• 00643169452398: GUIDE WIRE GWR419688 108CM GLOBAL CE