Medtronic Resuable Instruments

GUDID 00613994285102

HOLDER 9874145 STAND ALONE

MEDTRONIC SOFAMOR DANEK, INC.

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• Primary Device ID: 00613994285102
• NIH Device Record Key: fea5c447-bce8-4ae8-86b2-e46de85d50ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic Resuable Instruments
• Version Model Number: 9874145
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994285102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071416

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

Moist Heat or Steam Sterilization

[00613994285102]

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: 2015-08-19

On-Brand Devices [Medtronic Resuable Instruments]

• 00613994309266: POPPER 7971001 SMALL
• 00613994285133: TRIAL 9874139 DOUBLE-ENDED 39MM 41MM
• 00613994285119: TRIAL 9874143 DOUBLE-ENDED 43MM 45MM
• 00613994285102: HOLDER 9874145 STAND ALONE
• 00613994285096: PLATE HOLDER 9874640 4 HOLE
• 00613994284983: HOLDER 9870001 4HOLE PLATE FREE HAND
• 00613994284914: TRIAL 9874135 DOUBLE-ENDED 35MM 37MM
• 00613994284907: GUIDE 9874133 DBL BARREL 0 DEG
• 00613994265579: TRIAL 9359525 25MM
• 00613994265562: TRIAL 9359522 22MM
• 00613994265555: TRIAL 9359519 19MM
• 00613994265548: TRIAL 9359516 16MM
• 00613994265531: TRIAL 9359513 13MM
• 00673978957814: INNER TRAY 902-916 ANTERIOR 16MM INST
• 00673978070001: CASE 875-947L LID
• 00673978010076: CASE 175-947M M CURETTE MODULE
• 00673978010069: CASE 175-947 TRAY DC M CURETTES
• 00673978006192: CASE 105-121 L-BRACKETS
• 00673978006017: CASE 105-102 LID
• 00643169930186: RASP X1116036 CURVED
• 00643169888777: RASP EX0916019 9MM X 12MM X 16MM
• 00643169888760: RASP EX0916018 8MM X 12MM X 16MM
• 00643169888753: RASP EX0916017 7MM X 12MM X 16MM
• 00643169709652: RASP X0715055 OVAL
• 00643169692121: RASP EX0915004 CURVED WITH REVERSE ANGLE
• 00643169692091: SHAVER X0815078 15MM W/T HANDLE
• 00643169692084: SHAVER X0815077 14MM W/T HANDLE
• 00643169692077: SHAVER X0815076 13MM W/T HANDLE
• 00643169692060: SHAVER X0815075 12MM W/T HANDLE
• 00643169692053: SHAVER X0815074 11MM W/T HANDLE
• 00643169692046: SHAVER X0815073 10MM W/T HANDLE
• 00643169692039: SHAVER X0815072 9MM W/T HANDLE
• 00643169692022: SHAVER X0815071 8MM W/T HANDLE
• 00643169692015: SHAVER X0815070 7MM W/T HANDLE
• 00643169555310: RASP EX0814164
• 00643169349384: TRAY 9010000576 ISP CORTICAL WEDGE
• 00613994306265: DRIVER 8675203 5MM HEX
• 00613994306227: DRIVER 8675207 LONG
• 00763000051372: DRILL GUIDE EX0817038 20MM
• 00763000051365: DRILL GUIDE EX0817037 18MM
• 00763000051358: DRILL GUIDE EX0817036 16MM
• 00763000051341: DRILL GUIDE EX0817035 14MM
• 00763000051334: DRILL GUIDE EX0817034 12MM
• 00763000015688: DTS EX0517063 VARIABLE ANGLE
• 00763000015206: GUIDE X0517023 ADJSTBLE DPTH VRABLE DRLL
• 00763000011192: DTS GUIDE EX0517086 SNGL BARREL VARIABLE
• 00763000010904: DRILL GUIDE EX0517006 12MM
• 00763000010249: ATTACHMENT X0517005 FLEX ARM
• 00763000007508: GUIDE EX0517009 12MM DRILL NARROW
• 00763000001940: GUIDE EX0117065 DTS WITH TROCAR TIP