Duns Number:801895244
Device Description: Wide-Seal Silicone Vaginal Diaphragm; Size 95
Catalog Number
-
Brand Name
Arcing Diaphragm
Version/Model Number
MXWS95
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
-
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
K063223
Product Code
HDW
Product Code Name
Diaphragm, Contraceptive (And Accessories)
Public Device Record Key
4519f729-1bf6-4341-88fa-4f5c6fd14f5f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 15, 2015
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 | 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 |