Microtable System 002

GUDID 00196852534531

The Microtable System is a patient-specific surgical adapter designed to be secured on a skull-based anchor mounting set to hold and align surgical instruments with patient anatomy and to allow selected targets to be reached with sub-millimeter accuracy.

Gsb LLC

Neurological stereotactic surgery system

• Primary Device ID: 00196852534531
• NIH Device Record Key: d1bb57d4-6456-4793-92e1-6879f2db4e52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microtable System
• Version Model Number: D
• Catalog Number: 002
• Company DUNS: 079198739
• Company Name: Gsb LLC
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196852534531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132611

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

[00196852534531]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-27
• Device Publish Date: 2024-05-17