Duns Number:690543319
Device Description: RUNTHROUGH NS Extra Floppy PTCA Guidewire
Catalog Number
TW*AS418XA
Brand Name
RUNTHROUGH
Version/Model Number
25-1011
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
336cc967-1e50-4173-9894-cc5186b6fa38
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 09, 2016
Package DI Number
34987350779374
Quantity per Package
5
Contains DI Package
04987350779373
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfbox
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |
| 3 | A medical device with high risk that requires premarket approval | 29 |