LungVision Tool - The LungVision Tool is an instrument designed as - BODY VISION MEDICAL LTD

Duns Number:600280073

Device Description: The LungVision Tool is an instrument designed as a working channel intended to be used wit The LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system. LungVision Tool, LV2055020 is compatible with Olympus Bronchoscope BF-1TH160/180 LungVision Tool composed from: LungVision Handle, LungVision Adaptor with seal for Olympus Bronchoscope BF-1TH160/180, LungVision 210 Curved Sheath and LungVision Stylet

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More Product Details

Catalog Number

LV2055020

Brand Name

LungVision Tool

Version/Model Number

Bridge

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172955

Product Code Details

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Device Record Status

Public Device Record Key

7fb34a5d-fa3e-4a22-a3db-1870e52a5810

Public Version Date

May 27, 2022

Public Version Number

2

DI Record Publish Date

July 12, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BODY VISION MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19