Thoratec® HeartMate 3™ Surgical Hand Tools 10002222US

GUDID 00813024013259

HM3 Surgical Hand Tools

Thoratec Corporation

Cardiothoracic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00813024013259
• NIH Device Record Key: 93a8fa37-e937-4ed9-9b5a-4600820c69da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thoratec® HeartMate 3™ Surgical Hand Tools
• Version Model Number: 10002222US
• Catalog Number: 10002222US
• Company DUNS: 070156955
• Company Name: Thoratec Corporation
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024013259 [Primary]

FDA Product Code

• DSQ: Ventricular (Assisst) Bypass

Sterilization

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

[00813024013259]

Moist Heat or Steam Sterilization

[00813024013259]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-06-20
• Device Publish Date: 2017-08-30

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• 05415067038760 - HeartMate 3™: 2022-06-22 Coring Tool
• 05415067039286 - HeartMate 3™: 2022-06-22 Apical Cuff
• 05415067039361 - HeartMate 3™: 2022-06-22 Skin Coring Punch
• 15415067039481 - HeartMate 3™: 2022-06-22 Thread Protectors
• 05415067033758 - HeartMate Touch™: 2020-07-02 Communication System
• 05415067032058 - HeartMate Touch™: 2020-05-12 Communication System