LungVision SmartWire LV2055050

GUDID 07290017652191

The LungVision SmartWire is an instrument designed as a stylet/wire intended to be used with 3rd party bronchoscopes and robotic bronchoscopes to mark the target area, specifically within the respiratory system

BODY VISION MEDICAL LTD

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Primary Device ID	07290017652191
NIH Device Record Key	cf9001f8-e687-4036-adaf-c603feb884af
Commercial Distribution Status	In Commercial Distribution
Brand Name	LungVision SmartWire
Version Model Number	Bridge
Catalog Number	LV2055050
Company DUNS	600280073
Company Name	BODY VISION MEDICAL LTD
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	07290017652191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172955

FDA Product Code

EOQ	Bronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-10-21
Device Publish Date	2021-10-13

Devices Manufactured by BODY VISION MEDICAL LTD

07290017652108 - LungVision Tool	2022-05-27 The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy
07290017652153 - LungVision Tool	2021-10-28 The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy
07290017652160 - LungVision Tool	2021-10-28 The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy
07290017652177 - LungVision Tool	2021-10-28 The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy
07290017652184 - LungVision Tool	2021-10-28 The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy
07290017652191 - LungVision SmartWire	2021-10-21The LungVision SmartWire is an instrument designed as a stylet/wire intended to be used with 3rd party bronchoscopes and robotic bronchoscopes to mark the target area, specifically within the respiratory system
07290017652191 - LungVision SmartWire	2021-10-21 The LungVision SmartWire is an instrument designed as a stylet/wire intended to be used with 3rd party bronchoscopes and robotic
07290017652115 - LungVision Tool	2021-07-20 The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy
07290017652122 - LungVision Tool	2021-07-20 The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy