BONE GRAFT WASHER

GUDID 00613994543578

WASHER X050710319 19MM CLOVER

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00613994543578
• NIH Device Record Key: 9e28f4fc-b3f2-4008-a86c-1680f3b19a08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONE GRAFT WASHER
• Version Model Number: X050710319
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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: 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
• 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 Dimensions

• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994543578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994122

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

[00613994543578]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-02

On-Brand Devices [BONE GRAFT WASHER]

• 00613994543578: WASHER X050710319 19MM CLOVER
• 00673978958934: WASHER 9090117 TI BONE GRAFT 17MM
• 00673978958910: WASHER 9090115 TI BONE GRAFT 15MM