Guidance handpiece 5300

GUDID 00854763006089

Disposable handpiece connects to generator

HALT MEDICAL, INC

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• Primary Device ID: 00854763006089
• NIH Device Record Key: e9ef58f0-dbff-4d4a-9bcb-384bdae2c747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guidance handpiece
• Version Model Number: 5300
• Catalog Number: 5300
• Company DUNS: 602783495
• Company Name: HALT MEDICAL, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00854763006089 [Primary]

FDA Product Code

• HFG: Coagulator, Laparoscopic, Unipolar (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

Devices Manufactured by HALT MEDICAL, INC

• 00854763006003 - Handpiece: 2018-03-29 Disposable handpiece used for deliver RF energy to a target tissue.
• 00854763006010 - Pads: 2018-03-29 Dispersive pad connects to the generator
• 00854763006027 - Handpiece cable: 2018-03-29 Cable connects the handpiece to the generator
• 00854763006034 - Generator: 2018-03-29 RF Generator
• 00854763006041 - Guidance controller: 2018-03-29 Guidance magnetic tracking controller
• 00854763006058 - Guidance ultrasound transducer sleeve: 2018-03-29 Sterile Disposable Guidance Ultrasound Transducer Sleeve
• 00854763006065 - Guidance field generator: 2018-03-29 The Table Top Field Generator (TTFG) generates a magnetic field that is picked up by the magnetic guidance sensors
• 00854763006072 - Pad cable: 2018-03-29 Cable connects the pads to the generator