NaviNetics Driver Handle

GUDID 10850023620245

Navinetics, 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 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: 10850023620245
• NIH Device Record Key: 1d22c48e-7487-45ea-9dce-f84c8bd8c037
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviNetics Driver Handle
• Version Model Number: NN0110
• Company DUNS: 838320260
• Company Name: Navinetics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850023620245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231392

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: 2023-11-20
• Device Publish Date: 2023-11-10

Devices Manufactured by Navinetics, Inc.

• 10850023620245 - NaviNetics Driver Handle: 2023-11-20
• 10850023620245 - NaviNetics Driver Handle: 2023-11-20
• 10850023620269 - NaviNetics Standard Skull Anchor Screw: 2023-11-20
• 10850023620276 - NaviNetics Skull Anchor Key and Drill: 2023-11-20
• 10850023620177 - NaviNetics Cannula and Stylet Kit (To Target): 2023-08-01
• 10850023620184 - NaviNetics Microdrive Adapter A: 2023-08-01
• 10850023620191 - NaviNetics Microdrive Adapter F: 2023-08-01
• 10850023620207 - NaviNetics Skull Anchor Extended Screw Kit: 2023-08-01
• 10850023620214 - NaviNetics Skull Anchor Extended Rescue Screw Kit: 2023-08-01