Duns Number:967358115
Catalog Number
DSF1633
Brand Name
GORE DRYSEAL FLEX Introducer Sheath
Version/Model Number
DSF1633
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160254
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
0956ddd3-8d9d-4d8b-b34a-aa86d92698d3
Public Version Date
February 28, 2020
Public Version Number
4
DI Record Publish Date
July 22, 2016
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. | 561 |
3 | A medical device with high risk that requires premarket approval | 623 |