Duns Number:015986592
Device Description: Steerable Sheath, Bidirectional
Catalog Number
SS8FMB74
Brand Name
Vado
Version/Model Number
SS8FMB74
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2018
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
-
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
11b48a0a-61fb-4d1e-b950-b3700b3c29d6
Public Version Date
March 05, 2020
Public Version Number
5
DI Record Publish Date
May 19, 2017
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. | 5 |