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 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.
Catalog Number
80239
Brand Name
SET Rotarex™S 8 F x 110 cm
Version/Model Number
80239
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
76f71ad4-e301-4b56-92df-51989d3a734e
Public Version Date
May 12, 2022
Public Version Number
1
DI Record Publish Date
May 04, 2022
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 |