Duns Number:014789663
Device Description: CUBE PESSARY W/ DRAINAGE HOLES #2
Catalog Number
-
Brand Name
Premier
Version/Model Number
1040402
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K031463
Product Code
HHW
Product Code Name
Pessary, Vaginal
Public Device Record Key
92db522d-0295-4941-8b71-fc82dcf15260
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 16, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 130 |
2 | A medical device with a moderate to high risk that requires special controls. | 332 |