TRACKER 215187

GUDID 10886705004607

TRACKER MODULE

DEPUY MITEK, LLC

Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable Orthopaedic guidewire, reusable

• Primary Device ID: 10886705004607
• NIH Device Record Key: db8f4021-fc2d-432a-b61b-0762ebfc68b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACKER
• Version Model Number: 215187
• Catalog Number: 215187
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705004607 [Primary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

[10886705004607]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-09-01

On-Brand Devices [TRACKER]

• 10886705006564: TRACKER RETRACTOR
• 10886705006663: TRACKER ANCHOR PIN 2.0mm x 77mm
• 10886705006656: TRACKER ANCHOR PIN 2.0mm x 64mm
• 10886705006649: TRACKER ANCHOR PIN 2.0mm x 45mm
• 10886705006632: TRACKER DRILL BIT 4.5mm x 16.5cm
• 10886705006625: TRACKER DRILL BIT 3.2mm x 17.8cm
• 10886705006618: TRACKER DRILL BIT 2.0mm x 16.5cm
• 10886705006601: TRACKER POSITIONING CARD
• 10886705006595: TRACKER BONE CLAMP
• 10886705006588: TRACKER ANCHOR PIN PULLER
• 10886705006571: TRACKER SLOPE SELECTOR ARM
• 10886705004607: TRACKER MODULE