Duns Number:657528899
Device Description: The flexible silicone pessary is commonly used for a mild first or second-degree uterine p The flexible silicone pessary is commonly used for a mild first or second-degree uterine prolapse or procidentia.
Catalog Number
-
Brand Name
NA
Version/Model Number
M6-P
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
K092981
Product Code
HHW
Product Code Name
Pessary, Vaginal
Public Device Record Key
552c9551-2be8-4fd9-9bed-4133fd252523
Public Version Date
June 25, 2020
Public Version Number
4
DI Record Publish Date
August 18, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 676 |
| U | Unclassified | 1 |