NaviNetics MR Localizer Kit

GUDID 10850023620030

Navinetics, Inc.

Neurological stereotactic surgery system

• Primary Device ID: 10850023620030
• NIH Device Record Key: a6e7d0eb-f3f3-4283-ae6e-502a7b505aed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviNetics MR Localizer Kit
• Version Model Number: NN0130
• Company DUNS: 838320260
• Company Name: Navinetics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	10850023620030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210700

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: 2022-11-16
• Device Publish Date: 2022-11-08

Devices Manufactured by Navinetics, Inc.

• 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