STEREOTACTIC

GUDID 00650551149699

LEKSELL UPPER GUIDE BUSHING FOR 4.5MM DRILL

PMT CORPORATION

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