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

Bronchoscopic catheter

• 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