Duns Number:103169095
Device Description: Adapter set for EBUS, Single Use, 1 set
Catalog Number
-
Brand Name
Adapter set for EBUS
Version/Model Number
ASFEBUS3
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JRJ
Product Code Name
Unit, Drying
Public Device Record Key
f08e10d7-0ec1-4ef5-bf43-983381dad92e
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
July 15, 2021
Package DI Number
10843356100669
Quantity per Package
120
Contains DI Package
00843356100662
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 146 |