DIAM™ Spinal Stabilization System

GUDID 00613994406392

TRAY 9491227 DIAM LOWER

MEDTRONIC SOFAMOR DANEK, INC.

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• Primary Device ID: 00613994406392
• NIH Device Record Key: 1336eff1-579c-4683-8fe5-8480838ba5ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIAM™ Spinal Stabilization System
• Version Model Number: 9491227
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• 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)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	00613994406392 [Primary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

[00613994406392]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-24
• Device Publish Date: 2022-10-15

On-Brand Devices [DIAM™ Spinal Stabilization System]

• 00885074041384: CASE 9491217 INSTRUMENT TRAY 1 BOTTOM
• 00885074041377: CASE 9491216 INS TRAY 2 TOP
• 00721902938825: CASE 9491210 DIAM OUTER BASE
• 00613994243928: CASE 9491224 DIAM INSERTER INSTRUMENT TR
• 00613994406392: TRAY 9491227 DIAM LOWER
• 00613994243935: CASE 9491230 DIAM STAPLE CADDY