POWEREASE™ Instruments

GUDID 00643169013100

TAP 2342425 4.5-5.5MM SELF DRILLING TAP

MEDTRONIC SOFAMOR DANEK, INC.

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable

• Primary Device ID: 00643169013100
• NIH Device Record Key: 7752e711-e239-417b-87e8-3e2c4fabdd9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWEREASE™ Instruments
• Version Model Number: 2342425
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169013100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123270

FDA Product Code

• GWF: STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Sterilization

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

[00643169013100]

Moist Heat or Steam Sterilization

[00643169013100]

Moist Heat or Steam Sterilization

[00643169013100]

Moist Heat or Steam Sterilization

[00643169013100]

Moist Heat or Steam Sterilization

[00643169013100]

Moist Heat or Steam Sterilization

[00643169013100]

Moist Heat or Steam Sterilization

[00643169013100]

Moist Heat or Steam Sterilization

[00643169013100]

Moist Heat or Steam Sterilization

[00643169013100]

Moist Heat or Steam Sterilization

[00643169013100]

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: 2016-04-17

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