TRAcelet™

GUDID 20643169900909

COMPRESSION DEVICE TRACR TRACELET 5PK GL

MEDTRONIC, INC.

Radial artery compression device

• Primary Device ID: 20643169900909
• NIH Device Record Key: 60da22f8-b166-41f4-be04-f18735312827
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAcelet™
• Version Model Number: TRACR
• 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: 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

• Length: 19.2 Centimeter
• Length: 19.2 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperatures, or high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperatures, or high humidity during storage.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169900905 [Primary]
GS1	20643169900909 [Package]; Contains: 00643169900905; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162027

FDA Product Code

• DXC: CLAMP, VASCULAR

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: 2017-01-15

On-Brand Devices [TRAcelet™]

• 20643169900909: COMPRESSION DEVICE TRACR TRACELET 5PK GL
• 20643169900893: COMPRESSION DEVICE TRACL TRACELET 5PK GL