Duns Number:152008371
Device Description: Guidewire 2.0x230mm Sgl Trocar
Catalog Number
K230-20S
Brand Name
Vilex Guidewire
Version/Model Number
K230-20S
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
-
Product Code
HXI
Product Code Name
Passer, Wire, Orthopedic
Public Device Record Key
589a4303-a6e5-40b6-ac33-991c92930923
Public Version Date
May 25, 2020
Public Version Number
3
DI Record Publish Date
August 08, 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 | 345 |
2 | A medical device with a moderate to high risk that requires special controls. | 540 |