Duns Number:113008515
Device Description: PREMARIN (conjugated estrogens) Vaginal Cream—Each gram contains 0.625 mg conjugated estro PREMARIN (conjugated estrogens) Vaginal Cream—Each gram contains 0.625 mg conjugated estrogens, USP. Combination package: Each contains a net wt. of 1.06 oz (30 g) tube with plastic applicator(s)calibrated in 0.5 g increments to a maximum of 2 g
Catalog Number
-
Brand Name
Premarin (conjugated estrogens) vaginal cream
Version/Model Number
NDC 0046-0872-21
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
-
Product Code
HGD
Product Code Name
APPLICATOR, VAGINAL
Public Device Record Key
a4f65849-1c88-41eb-81de-aa3bda675fc7
Public Version Date
December 17, 2020
Public Version Number
2
DI Record Publish Date
September 24, 2020
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 | 2 |