Duns Number:801895244
Device Description: 95% Rigid Gellhorn Pessary; 1 1/2" (38mm)
Catalog Number
-
Brand Name
Milex
Version/Model Number
MXPGRS1-1/2
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"
Yes
For Single-Use
Yes
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
K904774
Product Code
HHW
Product Code Name
Pessary, Vaginal
Public Device Record Key
a75e4da5-bacd-4916-8922-50e33690c1bb
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
July 26, 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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |