Synergy®Cranial

GUDID 00763000631642

SW KIT 9733937 SYNERGY CRANIAL S7 2.2.9

MEDTRONIC NAVIGATION, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00763000631642
• NIH Device Record Key: 4c1b3ab2-6371-4f10-b323-91d6b2c544c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergy®Cranial
• Version Model Number: 9733937
• Company DUNS: 835233107
• Company Name: MEDTRONIC NAVIGATION, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000631642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221087

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [Synergy®Cranial]

• 00643169510616: SW KIT 9734068 SYN CRAN S7 PLNG STN EUSE
• 00643169510609: SW KIT 9734068 SYN CRAN S7 PLNG STN EU-E
• 00643169510593: SWKIT 9734068 SYN CRAN S7 PLNG STN SCAND
• 00643169510586: SW KIT 9734068 SYN CRAN S7 PLNG STN EUSW
• 00643169503311: SOFTWARE 9733763 SYNERGY CRANIAL S7
• 00643169481268: SFTWR KIT 9734068 SYN CRANI S7 PLNG STN
• 00763000253158: SOFTWARE 9733763 SYNERGY CRANIAL S7
• 00763000631703: SWKT 9734068 SYN CRANI S7 2.2.9 PLNG STN
• 00763000631642: SW KIT 9733937 SYNERGY CRANIAL S7 2.2.9
• 00763000631628: SW 9733763 SYNERGY CRANIAL S7 2.2.9