Synergy®Cranial

GUDID 00763000631642

SW KIT 9733937 SYNERGY CRANIAL S7 2.2.9

MEDTRONIC NAVIGATION, INC.

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