Duns Number:829568273
Device Description: POISE IMPRESSA BLADDER SUPPORT DEVICE MIXED 4-CS DIS 16 PKG
Catalog Number
-
Brand Name
Poise
Version/Model Number
Pessary
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 16, 2019
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HHW
Product Code Name
PESSARY, VAGINAL
Public Device Record Key
59951147-80ac-4a95-8919-444baccb3b99
Public Version Date
May 16, 2019
Public Version Number
3
DI Record Publish Date
September 23, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 141 |