General Instruments

GUDID 00763000845025

TOOL 5596048 DRIVER ASSEMBLY TOOL

MEDTRONIC SOFAMOR DANEK, INC.

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• Primary Device ID: 00763000845025
• NIH Device Record Key: e03fb98b-05cc-4a3d-839c-e0cc5348d33a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General Instruments
• Version Model Number: 5596048
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000845025 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00763000845025]

Moist Heat or Steam Sterilization

[00763000845025]

Moist Heat or Steam Sterilization

[00763000845025]

Moist Heat or Steam Sterilization

[00763000845025]

Moist Heat or Steam Sterilization

[00763000845025]

Moist Heat or Steam Sterilization

[00763000845025]

Moist Heat or Steam Sterilization

[00763000845025]

Moist Heat or Steam Sterilization

[00763000845025]

Moist Heat or Steam Sterilization

[00763000845025]

Moist Heat or Steam Sterilization

[00763000845025]

Moist Heat or Steam Sterilization

[00763000845025]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-11
• Device Publish Date: 2024-03-02

On-Brand Devices [General Instruments]

• 00763000583439: BENDER 5596008 IN-SITU 4.75/5.0 LEFT
• 00763000583422: BENDER 5596007 IN-SITU 4.75/5.0 RIGHT
• 00763000583415: BENDER 5596006 IN-SITU 5.5-6.35 LEFT
• 00763000583408: BENDER 5596005 IN-SITU 5.5-6.35 RIGHT
• 00763000585006: DRIVER 5598051 N/BRK-OFF SET SCR REDUCER
• 00763000584993: DRIVER 5598048 NON-BREAK-OFF PROVISIONAL
• 00763000584986: DRIVER 5598047 NON-BREAK-OFF SWIZZLE
• 00763000584979: SLEEVE 5597545 RED HEAD DEROTATION
• 00763000584962: REDUCER 5597510 CLOSED
• 00763000584955: REDUCER 5597500 OPEN
• 00763000584948: DRIVER 5597185 T-HANDLE MT25
• 00763000584931: DRIVER 5597070 BRK-OFF SET SCREW REDUCER
• 00763000583750: HEAD INSERTER 5599130 LOCKING
• 00763000583743: DRIVER 5598049 NON-BREAK-OFF FINAL
• 00763000583736: SLEEVE 5597740 STABILIZATION GUIDE
• 00763000583705: INSTRUMENT 5597550 SHANK EXTENDER
• 00763000583699: ADAPTER 5597520 SMARTLINK
• 00763000583682: REDUCER 5597501 THREADED-INNER
• 00763000583675: REDUCER 5597450 MDX BEALE ROCKER HOLES
• 00763000583668: ROD BENDER 5597255 ACUTE ANGLE
• 00763000583651: ROD BENDER 5597250 FRENCH-DUAL SIDED
• 00763000583644: HEAD TURNER 5597180 INLINE
• 00763000583637: HOOK TRIAL 5597178 WIDE BLADE L
• 00763000583620: HOOK TRIAL 5597177 WIDE BLADE S-M
• 00763000583613: HOOK TRIAL 5597176 OFFSET L-R
• 00763000583606: HOOK TRIAL 5597175 TRANSVERSE L-R
• 00763000583590: HOOK TRIAL 5597174 TAH TRV PROC S-M
• 00763000583583: HOOK TRIAL 5597173 EXTENDED BODY M-L
• 00763000583576: HOOK TRIAL 5597172 NARROW BLADE S-M
• 00763000583569: HOOK TRIAL 5597171 PEDICLE S-M
• 00763000583552: HOLDER 5597170 LATERAL IMPLANT
• 00763000583545: TOOL 5597160 DECORTICATION
• 00763000583538: TAB BREAKER 5597141 RETAINING
• 00763000583521: COUNTERTORQUE 5597120 MANUAL RED PLS PKT
• 00763000583514: HEAD INSERTER 5597110 PROVISIONAL
• 00763000583507: GRIPPER 5597060 6.0/6.35 ROD
• 00763000583491: GRIPPER 5597055 5.5 ROD
• 00763000583484: GRIPPER 5597050 4.75/5.0 ROD
• 00763000583460: PROBE 5597030 PEDICLE SMALL
• 00763000583453: INSTRUMENT 5597027 UAS DIRECTION GUIDE
• 00763000583446: HEAD TURNER 5597020 OFFSET
• 00763000845025: TOOL 5596048 DRIVER ASSEMBLY TOOL