STEREOTACTIC

GUDID 00650551149699

LEKSELL UPPER GUIDE BUSHING FOR 4.5MM DRILL

PMT CORPORATION

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: 00650551149699
• NIH Device Record Key: ee383602-8c0d-4256-ac3e-5091ada649d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STEREOTACTIC
• Version Model Number: 2103-212
• Company DUNS: 039576871
• Company Name: PMT CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00650551149699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831329

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

[00650551149699]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-22
• Device Publish Date: 2021-07-14

On-Brand Devices [STEREOTACTIC]

• 00650551144298: NEUROMATE BUSHING FOR 2.1MM DRILL
• 00650551144182: TWO PIECE BUSHING FOR VERTEK AND BRAINLAB SEEG CRANIOTOMY IMPLANT
• 00650551144526: VERTEK 1-PIECE BUSHING FOR USE WITH 1.2MM STYLET
• 00650551148821: BUSHING FOR LEKSELL LOWER GUIDE BUSHING FOR 2.4MM DRILL/DRIVER, 83MM LENGTH
• 00650551148623: BRAINLAB/VERTEK BUSHING FOR 2.4MM DRILL/DRIVER, 70MM LENGTH
• 00650551149699: LEKSELL UPPER GUIDE BUSHING FOR 4.5MM DRILL
• 00650551149682: LEKSELL UPPER GUIDE BUSHING FOR 3.3MM DRILL