Duns Number:330926895
Device Description: Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and O Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Catalog Number
FG-08060
Brand Name
DuraSheath Introducer Sheath System
Version/Model Number
8F, 60cm, straigth
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
-
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
d1057c3e-376f-470c-aabc-fb2316a2144d
Public Version Date
April 21, 2021
Public Version Number
2
DI Record Publish Date
June 30, 2019
Package DI Number
24251244500478
Quantity per Package
1
Contains DI Package
14251244500471
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugate
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |