GUDID 20643169843060

STEERING HANDLE 008958 TJM 5PK

MEDTRONIC, INC.

Torque manipulation device

• Primary Device ID: 20643169843060
• NIH Device Record Key: d9313d38-1168-4b2e-8697-d690d1c4a3dd
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 008958
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store accessories in a clean, cool and dark area.
• Special Storage Condition, Specify: Between 0 and 0 *Store accessories in a clean, cool and dark area.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169843066 [Primary]
GS1	20643169843060 [Package]; Contains: 00643169843066; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945461

FDA Product Code

• DTL: Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-06
• Device Publish Date: 2018-07-06

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