Duns Number:064730456
Device Description: Adapters are packed in a sealed bag containing one each the following sizes: 6, 7, 8, 9, a Adapters are packed in a sealed bag containing one each the following sizes: 6, 7, 8, 9, and 10mm. Adapters are compatible with the WomanCare Global Ipas MVA Plus® Aspirator. Adapters are color-coded using a different color for each size, 6mm (blue), 7mm (light brown), 8mm (white), 9mm (dark brown), and 10mm (green). Adapters have wings for facilitation of adding and removing from aspirator. Adapters can be reused a maximum of 25 times.
Catalog Number
-
Brand Name
WomanCare Global Adapter Set
Version/Model Number
ADP-SET
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"
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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
HGH
Product Code Name
Cannula, Suction, Uterine
Public Device Record Key
d03e80f0-c4b8-4cf4-8d61-1b3f85b3a570
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 |