Duns Number:015823456
Device Description: Bronchoscope Patient Introducer Kit
Catalog Number
MBR-000017
Brand Name
Bronchoscope Patient Introducer Kit
Version/Model Number
MBR-000017
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K173760,K173760
Product Code
EOQ
Product Code Name
Bronchoscope (Flexible Or Rigid)
Public Device Record Key
4a43c747-7d63-463b-a8e2-03ae9cd18645
Public Version Date
July 09, 2018
Public Version Number
1
DI Record Publish Date
June 08, 2018
Package DI Number
B634MBR0000171
Quantity per Package
4
Contains DI Package
B634MBR0000170
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 37 |