Duns Number:657528899
Device Description: The Pessary Remover is designed for removal of the pessaries easily. It is best used for t The Pessary Remover is designed for removal of the pessaries easily. It is best used for the removal of the ring, with or without support, the oval, dish, hodge or marland. When using the remover to remove the pessary, it must be used with lubricant.
Catalog Number
-
Brand Name
NA
Version/Model Number
PRM2
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"
-
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
-
Product Code
HHF
Product Code Name
Remover, Intrauterine Device, Contraceptive, Hook-Type
Public Device Record Key
543a0666-8c39-4ca3-a8e7-30be4c245d58
Public Version Date
June 25, 2020
Public Version Number
4
DI Record Publish Date
August 15, 2016
Package DI Number
04715309124963
Quantity per Package
25
Contains DI Package
04715309122235
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |