Duns Number:801895244
Device Description: KIT: Risser Folding Pessary #8; 3 7/8" x 3 7/16" (98mm x 87mm)
Catalog Number
-
Brand Name
MILEX
Version/Model Number
MXKPRI08
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
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
aa57f49a-a06b-45a0-9d3a-3d6d4bfc89e7
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
August 09, 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 |