Duns Number:064730456
Device Description: The device is used to evacuate the contents of the uterus. It consists of a 60cc syringe b The device is used to evacuate the contents of the uterus. It consists of a 60cc syringe barrel, plunger, collar stop, o-ring, and removable valve liner. Aspirators are compatible with cannulae size 3-6mm. Aspirator is sterile, clean, and single use.
Catalog Number
-
Brand Name
WomanCare Global Single-Valve Aspirator
Version/Model Number
SVS-S10
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
21a3e6d3-8db9-46c6-87f7-6bdac2b89d24
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
Package DI Number
10853615006359
Quantity per Package
10
Contains DI Package
00853615006352
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |