Duns Number:780024725
Device Description: EndoSheath Technology for BRS-5100 Video Bronchoscope
Catalog Number
04-5112
Brand Name
EndoSheath Technology
Version/Model Number
BVX-1.5
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091768,K091768
Product Code
EOQ
Product Code Name
Bronchoscope (Flexible Or Rigid)
Public Device Record Key
74e265b7-1258-471c-9f7f-1c4edf1e1f63
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
September 23, 2016
Package DI Number
20874485002408
Quantity per Package
10
Contains DI Package
00874485003111
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 33 |