Duns Number:964569052
Device Description: Hi-Torque Steelcore Bare Guide Wire .018” Microglide Coated Straight Tip 300 cm
Catalog Number
1050000
Brand Name
HI-TORQUE STEELCORE
Version/Model Number
1050000
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
K200144,K200144
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
08b8aa99-8f08-4c5b-900c-48d76fd97eee
Public Version Date
May 15, 2020
Public Version Number
1
DI Record Publish Date
May 07, 2020
Package DI Number
28717648239322
Quantity per Package
5
Contains DI Package
08717648239328
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 964 |
| 3 | A medical device with high risk that requires premarket approval | 775 |