NaviNetics Skull Anchor Key Kit

GUDID 10850023620061

Navinetics, Inc.

Neurological stereotactic surgery system

• Primary Device ID: 10850023620061
• NIH Device Record Key: 2a2a9143-4d72-4c77-9122-e99f3c3a482f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviNetics Skull Anchor Key Kit
• Version Model Number: NN1210
• Company DUNS: 838320260
• Company Name: Navinetics, 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: true
• 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	10850023620061 [Package]; Contains: 10850023620122; Package: Convenience Kit [5 Units]; In Commercial Distribution
GS1	10850023620122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210700

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[10850023620061]

Moist Heat or Steam Sterilization

[10850023620061]

Moist Heat or Steam Sterilization

[10850023620061]

Moist Heat or Steam Sterilization

[10850023620061]

Moist Heat or Steam Sterilization

[10850023620061]

Moist Heat or Steam Sterilization

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