Duns Number:078511333
Device Description: Pessary, Vaginal. Gellhorn pessary is used for a second to third degree prolapse, or proc Pessary, Vaginal. Gellhorn pessary is used for a second to third degree prolapse, or procidentia.
Catalog Number
GD
Brand Name
EvaCare Pessary
Version/Model Number
Gellhorn Pessary
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2025
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
K993308
Product Code
HHW
Product Code Name
Pessary, Vaginal
Public Device Record Key
aaf032ed-a6fa-4f1b-81fe-e6fb65fc3d81
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 06, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |