Duns Number:117446916
Device Description: PS SC-018-150 TRAILBLAZER V05
Catalog Number
-
Brand Name
TrailBlazer™
Version/Model Number
SC-018-150
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
K092299,K092299
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
a907efb9-6278-4035-9f9f-54f2809bc50a
Public Version Date
September 22, 2022
Public Version Number
4
DI Record Publish Date
February 28, 2019
Package DI Number
20763000104782
Quantity per Package
5
Contains DI Package
00763000104788
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 835 |
3 | A medical device with high risk that requires premarket approval | 96 |