Duns Number:064730456
Device Description: Accessory Kits are packed in a sealed bag containing one cap, one collar stop, one O-ring, Accessory Kits are packed in a sealed bag containing one cap, one collar stop, one O-ring, and one 2cc tube of silicone. The cap, collar stop and O-ring as components are suitable to be reused a maximum of 25 times.
Catalog Number
-
Brand Name
WomanCare Global Ipas MVA Plus® Aspirator Accessory Kit
Version/Model Number
AK-PLUS
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
-
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
5da09027-1f97-4ff8-9409-32e57753b261
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 |