Duns Number:529853921
Device Description: The ULTRASKIN Hydrophilic Guide Wire consists of a Nitinol core wire, a plastic jacket wit The ULTRASKIN Hydrophilic Guide Wire consists of a Nitinol core wire, a plastic jacket with hydrophilic coating. The wire distal curve comes in different shapes such as straight, J angled and angled. The guide wire is radiopactitive under fluoroscopy.
Catalog Number
-
Brand Name
ULTRASKIN
Version/Model Number
ST-S35150
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
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
b1e7e608-773b-44c3-a082-c95dbd616c8f
Public Version Date
June 28, 2018
Public Version Number
1
DI Record Publish Date
May 28, 2018
Package DI Number
16936733736859
Quantity per Package
5
Contains DI Package
06936733736852
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 89 |