SHILLA™ Growth Guidance System

GUDID 00613994798237

TRAY 7679064 5.5 INST 2

MEDTRONIC SOFAMOR DANEK, INC.

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• Primary Device ID: 00613994798237
• NIH Device Record Key: b1a5e335-10c5-470d-8706-064a3e10e9f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHILLA™ Growth Guidance System
• Version Model Number: 7679064
• 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: 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00613994798237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190840

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

[00613994798237]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [SHILLA™ Growth Guidance System]

• 00643169009943: TRAY 7679029 4.5 MAS
• 00643169009929: TRAY 7679027 4.5 FAS
• 00613994801333: LID 7679021 SHILLA 4.5 SCRW CADDY CS2
• 00613994800008: TRAY 7679001 SHLA 4.5 INSTR 1 CS 3
• 00613994799999: TRAY 7679002 SHLA 4.5 INSTR 2 CS 3
• 00613994799975: TRAY 7679004 SHLA 4.5 INSTR 1 CS 4
• 00613994799968: TRAY 7679005 SHLA 4.5 INSTR 2 CS 4
• 00613994799944: TRAY 7679007 SHLA 4.5 INSTR 1 CS 5
• 00613994799937: TRAY 7679008 SHLA 4.5 INSTR 2 CS 5
• 00613994799920: TRAY 7679009 SHLA 4.5 INSTR 3 CS 5
• 00613994799906: TRAY 7679011 SHLA 4.5 XLINK INST
• 00613994799876: TRAY 7679014 SHLA 4.5 FAS 1CS 1
• 00613994799852: TRAY 7679016 SHLA 4.5 MAS 2 CS 2
• 00613994799845: TRAY 7679017 SHLA 4.5 MAS 1 CS 2
• 00613994799838: CADDY 7679018 SHILLA 4.5 XLINK CDY CS 2
• 00613994799821: LID 7679019 SHLA 4.5 XLINK CDY CS 2
• 00613994799814: CADDY 7679020 SHLA 4.5 ST SCRW CS 2
• 00613994798367: TRAY 7679051 5.5 FAS 1
• 00613994798343: TRAY 7679053 5.5 MAS 2
• 00613994798336: TRAY 7679054 5.5 MAS 1
• 00613994798329: CADDY 7679055 1 SHILLA 5.5 CROSSLINK
• 00613994798299: CADDY LID 7679058 5.5 SET SCREW
• 00613994798275: TRAY 7679060 5.5 INST 1
• 00613994798268: TRAY 7679061 5.5 INST 2
• 00613994798244: TRAY 7679063 5.5 INST 1
• 00613994798237: TRAY 7679064 5.5 INST 2
• 00613994798213: TRAY 7679066 5.5 INST 1
• 00613994798206: TRAY 7679067 5.5 INST 2
• 00613994798190: TRAY 7679068 5.5 INST 3
• 00613994798176: TRAY 7679070 5.5 XLINK INST 1
• 00613994798312: LID 7679056 5.5 XLINK CDY
• 00613994798305: CADDY 7679057 5.5 SET SCREW
• 00613994803160: SCREWDRIVER 7674444 4.5 CANNULATED MAS