Guidance controller 5100

GUDID 00854763006041

Radio-frequency ablation system

Primary Device ID	00854763006041
NIH Device Record Key	67cc1b73-d7f4-472f-a0a3-4987140237cb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Guidance controller
Version Model Number	5100
Catalog Number	5100
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	false
Lot Batch	false
Serial Number	true
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 Issuing Agency	Device ID
GS1	00854763006041 [Primary]

HFG	Coagulator, Laparoscopic, Unipolar (And Accessories)

Steralize Prior To Use	false
Device Is Sterile	false

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	2018-03-29Guidance magnetic tracking controller
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