ThoraTrak™

GUDID 00643169615342

BLADE 28601 THORATRAK LIMA STD

MEDTRONIC, INC.

Rib spreader, reusable

• Primary Device ID: 00643169615342
• NIH Device Record Key: 4e9e808f-e34b-4c2e-919c-dc4960d8abd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThoraTrak™
• Version Model Number: 28601
• 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: 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169615342 [Direct Marking]
GS1	00763000058289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132645

FDA Product Code

• GAD: RETRACTOR

Sterilization

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

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

[00643169615342]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-02-16

On-Brand Devices [ThoraTrak™]

• 00643169615410: BLADE 28606B THORATRAK SHRT EXT INFR STD
• 00643169615403: BLADE 28604B THORATRAK LNG EXT INFR STD
• 00643169615397: BLADE 28606 THORATRAK SHRT THRCTMY DP
• 00643169615380: BLADE 28605 THORATRAK SHRT THRCTMY STD
• 00643169615373: BLADE 28604 THORATRAK LNG THRCTMY DP
• 00643169615366: BLADE 28603 THORATRAK LNG THRCTMY STD
• 00643169615359: BLADE 28602 THORATRAK LIMA DP
• 00643169615342: BLADE 28601 THORATRAK LIMA STD
• 00643169615335: RETRACTOR RACK 28611 THORATRAK