Duns Number:064730456
Device Description: The device is used to evacuate the contents of the uterus. The aspirator is double-valve, The device is used to evacuate the contents of the uterus. The aspirator is double-valve, consisting of a 60cc syringe barrel, plunger, collar stop, and removable valve liner. Aspirators are clean, not sterile, and single-use.
Catalog Number
-
Brand Name
WomanCare Global Double-Valve Aspirator
Version/Model Number
DVS-SU
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HHI
Product Code Name
System, Abortion, Vacuum
Public Device Record Key
60b5237b-4c8a-4d3e-9e5e-862e5223682a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
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 |