Medtronic Reusable Instruments

GUDID 00643169316546

TRIAL X1012428 0DEG 27MM x 16MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00643169316546
• NIH Device Record Key: 523b6ef9-03cf-4ed1-8331-290135c26b5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic Reusable Instruments
• Version Model Number: X1012428
• 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

Device Dimensions

• Length: 27 Millimeter
• Length: 27 Millimeter
• Length: 27 Millimeter
• Length: 27 Millimeter
• Length: 27 Millimeter
• Length: 27 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169316546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120368

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00643169316546]

Moist Heat or Steam Sterilization

[00643169316546]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-06-30

On-Brand Devices [Medtronic Reusable Instruments]

• 00613994900999: DISTRACTOR/TRIAL X1010843 6X26
• 00613994900982: DISTRACTOR/TRIAL X1010842 6X22
• 00613994898500: DISTRACTOR/TRIAL X09103461 12 X 8 X 22
• 00613994898494: DISTRACTOR/TRIAL X09103462 12 X 8 X 26
• 00613994898487: DISTRACTOR/TRIAL X09103463 12 X 8 X 32
• 00613994898470: DISTRACTOR/TRIAL X09103464 12 X 8 X 36
• 00613994898463: DISTRACTOR/TRIAL X09103465 12 X 10 X 22
• 00613994898456: DISTRACTOR/TRIAL X09103466 12 X 10 X 26
• 00613994898449: DISTRACTOR/TRIAL X09103467 12 X 10 X 32
• 00613994898432: DISTRACTOR/TRIAL X09103468 12 X 10 X 36
• 00613994898425: DISTRACTOR/TRIAL X09103469 12 X 12 X 22
• 00613994898418: DISTRACTOR/TRIAL X09103470 12 X 12 X 26
• 00613994898401: DISTRACTOR/TRIAL X09103471 12 X 12 X 32
• 00613994898395: DISTRACTOR/TRIAL X09103472 12 X 12 X 36
• 00613994898388: DISTRACTOR/TRIAL X09103473 12 X 14 X 22
• 00613994898371: DISTRACTOR/TRIAL X09103474 12 X 14 X 26
• 00613994898364: DISTRACTOR/TRIAL X09103475 12 X 14 X 32
• 00613994898357: DISTRACTOR/TRIAL X09103476 12 X 14 X 36
• 00613994898340: DISTRACTOR/TRIAL X09103477 12 X 16 X 22
• 00613994898333: DISTRACTOR/TRIAL X09103478 12 X 16 X 26
• 00613994898326: DISTRACTOR/TRIAL X09103479 12 X 16 X 32
• 00613994898319: DISTRACTOR/TRIAL X09103480 12 X 16 X 36
• 00613994808257: SCREW PFF0040 40MM FACET FIXATION ANCHOR
• 00613994808240: SCREW PFF0035 35MM FACET FIXATION ANCHOR
• 00613994808233: SCREW PFF0030 30MM FACET FIXATION ANCHOR
• 00613994808226: SCREW PFF0025 25MM FACET FIXATION ANCHOR
• 00613994806291: TRIAL 2981126 CAPSTONE 11 X 26MM
• 00613994806284: TRIAL 2981122 CAPSTONE 11 X 22MM
• 00613994806277: TRIAL 2980936 CAPSTONE 09 X 36MM
• 00613994806260: TRIAL 2980932 CAPSTONE 09 X 32MM
• 00613994806253: TRIAL 2980926 CAPSTONE 09 X 26MM
• 00613994806246: TRIAL 2980922 CAPSTONE 09 X 22MM
• 00613994806239: TRIAL 2980736 CAPSTONE 07 X 36MM
• 00613994806215: TRIAL 2980726 CAPSTONE 07 X 26MM
• 00613994806208: TRIAL 2980722 CAPSTONE 07 X 22MM
• 00613994806178: TRIAL 2980626 CAPSTONE 06 X 26MM
• 00613994806161: TRIAL 2980622 CAPSTONE 06 X 22MM
• 00613994806154: TRIAL 2981636 CAPSTONE 16 X 36MM
• 00613994806147: TRIAL 2981632 CAPSTONE 16 X 32MM
• 00613994806130: TRIAL 2981626 CAPSTONE 16 X 26MM
• 00613994806123: TRIAL 2981622 CAPSTONE 16 X 22MM
• 00613994806116: TRIAL 2981536 CAPSTONE 15 X 36MM
• 00613994806109: TRIAL 2981532 CAPSTONE 15 X 32MM
• 00613994806093: TRIAL 2981526 CAPSTONE 15 X 26MM
• 00613994806086: TRIAL 2981522 CAPSTONE 15 X 22MM
• 00613994806079: TRIAL 2981336 CAPSTONE 13 X 36MM
• 00613994806062: TRIAL 2981332 CAPSTONE 13 X 32MM
• 00613994806055: TRIAL 2981326 CAPSTONE 13 X 26MM
• 00613994806048: TRIAL 2981322 CAPSTONE 13 X 22MM
• 00613994806031: TRIAL 2981136 CAPSTONE 11 X 36MM