Duns Number:421256891
Device Description: Steerable Intracardiac Catheter Introducer Kit
Catalog Number
S08574LS
Brand Name
NA
Version/Model Number
S08574LS
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"
Yes
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
5c18fa5b-d592-4661-bccb-03011d92f9e6
Public Version Date
January 23, 2019
Public Version Number
3
DI Record Publish Date
November 15, 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. | 35 |