Duns Number:151047370
Device Description: VisiSheath™ Dilator Sheath
Catalog Number
501-216
Brand Name
VisiSheath™
Version/Model Number
501-216
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 06, 2019
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
-
Product Code
DRE
Product Code Name
Dilator, Vessel, For Percutaneous Catheterization
Public Device Record Key
65bedccb-6f60-4333-9834-2b4d0db8b521
Public Version Date
October 26, 2021
Public Version Number
5
DI Record Publish Date
August 19, 2014
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. | 251 |
3 | A medical device with high risk that requires premarket approval | 126 |