Duns Number:657528899
Device Description: "Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a "Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus.Vaginal Dilators has four different size (small, medium, large and extra large) in three family types; Family A, Family B and Family C with variant sizes."
Catalog Number
-
Brand Name
NA
Version/Model Number
DT-B-W
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130273
Product Code
HDX
Product Code Name
Dilator, Vaginal
Public Device Record Key
e344b0b9-15f6-4a2a-adb3-e4e5927869e5
Public Version Date
June 25, 2020
Public Version Number
4
DI Record Publish Date
August 18, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 676 |
| U | Unclassified | 1 |