Duns Number:801895244
Device Description: Wallace Ring Pessary PVC, 53 mm
Catalog Number
-
Brand Name
Wallace Ring Pessary PVC, 53 mm
Version/Model Number
700/300/053
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"
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
K012277,K012277
Product Code
HHW
Product Code Name
Pessary, Vaginal
Public Device Record Key
66920a17-7f8b-4046-93f1-35cc085f5ae5
Public Version Date
January 28, 2020
Public Version Number
1
DI Record Publish Date
January 20, 2020
Package DI Number
20888937020742
Quantity per Package
20
Contains DI Package
00888937020748
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 | 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 |