Duns Number:364614362
Device Description: Mustang Ultra Thin Condom, 3-Pack Case of 48
Catalog Number
-
Brand Name
Mustang Ultra Thin
Version/Model Number
99AKR93C
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 29, 2022
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)
Yes
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
HIS
Product Code Name
Condom
Public Device Record Key
96348db3-488d-4362-bf11-a4683e8e8a94
Public Version Date
June 30, 2022
Public Version Number
2
DI Record Publish Date
August 10, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 152 |