Duns Number:042823948
Device Description: Roadrunner UniGlide Hydrophilic Wire Guide
Catalog Number
HPWS-38-150
Brand Name
Roadrunner UniGlide
Version/Model Number
G56158
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 25, 2022
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
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
ec4521c5-3676-44f8-a8c7-eb645f060205
Public Version Date
May 26, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10827002561585
Quantity per Package
5
Contains DI Package
00827002561588
Package Discontinue Date
May 25, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |