THORATEC® ONE TUNNELER ASSEMBLY FULL CURVE, WITH ONE EXTRA TIP AND SHEATH 10002-6003-001

GUDID 00813024011385

Thoratec Corporation

Vascular graft tunneller

• Primary Device ID: 00813024011385
• NIH Device Record Key: 25848c4e-d6d7-415c-b97d-567fdb59a6d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THORATEC® ONE TUNNELER ASSEMBLY FULL CURVE, WITH ONE EXTRA TIP AND SHEATH
• Version Model Number: 10002-6003-001
• Catalog Number: 10002-6003-001
• 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: 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(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024011385 [Primary]

FDA Product Code

• DSQ: Ventricular (Assisst) Bypass
• DYB: Introducer, Catheter

Sterilization

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

[00813024011385]

Moist Heat or Steam Sterilization

[00813024011385]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-03-21
• Device Publish Date: 2014-09-20

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