Duns Number:080909607
Device Description: The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handhel The Aurora EVACUATOR is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remove fluids and soft tissue during minimally invasive surgical procedures.
Catalog Number
AE10F/70
Brand Name
AURORA Evacuator
Version/Model Number
AE10F/70
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K190075
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
c8485e13-3b46-4f5b-93d6-3dee3f90d501
Public Version Date
October 26, 2022
Public Version Number
5
DI Record Publish Date
February 06, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |