Duns Number:600280073
Device Description: The LungVision SmartWire is an instrument designed as a stylet/wire intended to be used wi 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
Catalog Number
LV2055050
Brand Name
LungVision SmartWire
Version/Model Number
Bridge
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
EOQ
Product Code Name
Bronchoscope (Flexible Or Rigid)
Public Device Record Key
cf9001f8-e687-4036-adaf-c603feb884af
Public Version Date
May 27, 2022
Public Version Number
2
DI Record Publish Date
October 13, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |