POWEREASE™ Instruments

GUDID 00613994905529

SLEEVE 2343429L 8.0MM NIM SLEEVE

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic stereotactic surgery system

• Primary Device ID: 00613994905529
• NIH Device Record Key: c5db0c17-5396-4f65-9f53-950270ccb27a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWEREASE™ Instruments
• Version Model Number: 2343429L
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00613994905529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111520

FDA Product Code

• GWF: STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Sterilization

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

[00613994905529]

Moist Heat or Steam Sterilization

[00613994905529]

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: 2016-04-16

On-Brand Devices [POWEREASE™ Instruments]

• 00613994952073: DRILL BIT G2345030S 3.0MM DRILL BIT
• 00613994952066: DRILL BIT G2345030M 3.0MM DRILL BIT
• 00613994952059: DRILL BIT G2345030L 3.0MM DRILL BIT
• 00613994952042: DRILL BIT G2345035S 3.5MM DRILL BIT
• 00613994952035: DRILL BIT G2345035M 3.5MM DRILL BIT
• 00613994952028: DRILL BIT G2345035L 3.5MM DRILL BIT
• 00613994952011: DRILL BIT G2345042S 4.2MM DRILL BIT
• 00613994952004: DRILL BIT G2345042M 4.2MM DRILL BIT
• 00613994951991: DRILL BIT G2345042L 4.2MM DRILL BIT
• 00613994917713: ROD CUTTER 2346030 ROD CUTTER
• 00613994917706: COUNTER TORQUE 2346013 5.5 OFFSET
• 00613994917690: COUNTER TORQUE 2346012 5.5/6.0 MAS/FAS
• 00613994917683: COUNTER TORQUE 2346011 4.75 MAS/FAS
• 00613994917676: BREAKOFF 2346010 SET SCREW BREAKOFF
• 00613994917652: DRILL BIT 2345042L 4.2MM DRILL BIT
• 00613994917645: DRILL BIT 2345042M 4.2MM DRILL BIT
• 00613994917638: DRILL BIT 2345042S 4.2MM DRILL BIT
• 00613994917621: DRILL BIT 2345035L 3.5MM DRILL BIT
• 00613994917614: DRILL BIT 2345035M 3.5MM DRILL BIT
• 00613994917607: DRILL BIT 2345035S 3.5MM DRILL BIT
• 00613994917591: DRILL BIT 2345030L 3.0MM DRILL BIT
• 00613994917584: DRILL BIT 2345030M 3.0MM DRILL BIT
• 00613994917577: DRILL BIT 2345030S 3.0MM DRILL BIT
• 00613994917539: TRAY 2397002 POWEREASE HANDPIECE
• 00613994907592: CABLE 2344000 POWEREASE NIM
• 00613994907448: CONSOLE 2340000 POWEREASE IPC
• 00613994905734: POST CUTTER 2346020 POST CUTTER
• 00613994905727: SCREWDRIVER 2342306M 5.5 MAS
• 00613994905710: SCREWDRIVER 2342306L 5.5 MAS
• 00613994905703: SCREWDRIVER 2342305S 4.75 MAS
• 00613994905697: SCREWDRIVER 2342305M 4.75 MAS
• 00613994905680: SCREWDRIVER 2342305L 4.75 MAS
• 00613994905673: SCREWDRIVER 2342301S 5.5 RMAS
• 00613994905666: SCREWDRIVER 2342301M 5.5 RMAS
• 00613994905659: SCREWDRIVER 2342301L 5.5 RMAS
• 00613994905642: SCREWDRIVER 2342300S 4.75 RMAS
• 00613994905635: SCREWDRIVER 2342300M 4.75 RMAS
• 00613994905628: SCREWDRIVER 2342300L 4.75 RMAS
• 00613994905611: SCREWDRIVER 2342281S 5.5 FAS
• 00613994905604: SCREWDRIVER 2342281M 5.5 FAS
• 00613994905598: SCREWDRIVER 2342281L 5.5 FAS
• 00613994905581: SCREWDRIVER 2342306S 5.5 MAS
• 00613994905574: SLEEVE 2343431S 9.0MM NIM SLEEVE
• 00613994905567: SLEEVE 2343431M 9.0MM NIM SLEEVE
• 00613994905550: SLEEVE 2343431L 9.0MM NIM SLEEVE
• 00613994905543: SLEEVE 2343429S 8.0MM NIM SLEEVE
• 00613994905536: SLEEVE 2343429M 8.0MM NIM SLEEVE
• 00613994905529: SLEEVE 2343429L 8.0MM NIM SLEEVE
• 00613994905512: SLEEVE 2343426S 6.5MM NIM SLEEVE
• 00613994905505: SLEEVE 2343426M 6.5MM NIM SLEEVE