Duns Number:401020409
Catalog Number
WG020132
Brand Name
Hydrophilic Nitinol Guide Wire, .032x150cm, standard, 3cm straight flexible tip
Version/Model Number
WG020132
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
EYA
Product Code Name
Stylet, Ureteral
Public Device Record Key
42866f0a-89e6-4bff-bd83-6bd6c031d625
Public Version Date
January 01, 2020
Public Version Number
4
DI Record Publish Date
September 14, 2016
Package DI Number
03700512985655
Quantity per Package
6
Contains DI Package
03700512975656
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box 2
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 152 |