Duns Number:021717889
Device Description: Guidewire and Guidewire Manipulation Device
Catalog Number
H802233300
Brand Name
RotaWire™ Elite and wireClip™ Torquer
Version/Model Number
H802233300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 21, 2016
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
P900056,P900056
Product Code
MCX
Product Code Name
CATHETER, CORONARY, ATHERECTOMY
Public Device Record Key
e798c180-4c9c-43e6-9dd5-358eb52f1256
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 29, 2015
Package DI Number
08714729862307
Quantity per Package
5
Contains DI Package
08714729862291
Package Discontinue Date
December 21, 2016
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |