Duns Number:014789663
Device Description: CUBE PESSARY W/O DRAINAGE HOLES #10
Catalog Number
-
Brand Name
Premier
Version/Model Number
1040421
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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)
Yes
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
5d8d41b2-ee59-4e19-8853-11dc2f9bf8d1
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 |