Duns Number:488489766
Device Description: Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex®S catheter Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex®S catheter (gauge 6F; length 135 cm), one guidewire (0.018” diameter; 320 cm in length), one drape and one collecting bag.
Catalog Number
80237
Brand Name
SET Rotarex®S 6F 135cm (Straub Medical®)
Version/Model Number
Version 1.0
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
08655da8-3266-4b38-a0c6-d28865fbb0b3
Public Version Date
June 07, 2022
Public Version Number
4
DI Record Publish Date
January 31, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |