Duns Number:008999906
Catalog Number
-
Brand Name
Warrior™ guidewire
Version/Model Number
7388
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 07, 2021
Issuing Agency
In HIBCC
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
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
db22c9b4-86a1-4c3e-beca-2423a02b1f06
Public Version Date
January 07, 2021
Public Version Number
4
DI Record Publish Date
March 07, 2018
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 238 |
U | Unclassified | 12 |