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
444483
Brand Name
Biotronik Fortress Introducer Sheath System
Version/Model Number
90 cm, 5F Straight
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
K153197,K153197
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
8bb06cef-738b-4c85-aad8-c371b60ca3c9
Public Version Date
June 07, 2019
Public Version Number
2
DI Record Publish Date
November 30, 2018
Package DI Number
14251244500587
Quantity per Package
5
Contains DI Package
04251244500580
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Packer
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |