Magnetic Controller, Magnetic Surgical System

GUDID 00852342007014

Magnetic Controller, Magnetic Surgical System

LEVITA MAGNETICS INTERNATIONAL CORPORATION

Magnetic surgical manipulation system instrument, external, permanent Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet Magnetic surgical manipulation system instrument, external, permanent magnet

• Primary Device ID: 00852342007014
• NIH Device Record Key: 37825990-b0b8-4ab0-bdeb-7a89ad3cba3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magnetic Controller, Magnetic Surgical System
• Version Model Number: MAG001
• Company DUNS: 066172261
• Company Name: LEVITA MAGNETICS INTERNATIONAL 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: 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	00852342007014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150007

FDA Product Code

• PNL: Magnetic Surgical System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-16

Devices Manufactured by LEVITA MAGNETICS INTERNATIONAL CORPORATION

• 00852342007038 - MARS Surgeon Controlled Arm: 2023-09-22 MARS Surgeon Controlled Arm
• 00852342007076 - MARS Scope Holder: 2023-09-22 MARS Scope Holder
• 00852342007007 - Toothed Grasper, Magnetic Surgical System: 2018-07-06 Magnetic Surgical System Toothed Grasper,
• 00852342007014 - Magnetic Controller, Magnetic Surgical System: 2018-07-06Magnetic Controller, Magnetic Surgical System
• 00852342007014 - Magnetic Controller, Magnetic Surgical System: 2018-07-06 Magnetic Controller, Magnetic Surgical System