Duns Number:001211952
Catalog Number
-
Brand Name
Trojan™ The Edge Changing Sensations Condom
Version/Model Number
00022600001324
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)
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
K120287,K912901
Product Code
HIS
Product Code Name
CONDOM
Public Device Record Key
62b20e5b-3ec2-434e-94f8-4d9556388d15
Public Version Date
May 17, 2019
Public Version Number
1
DI Record Publish Date
May 09, 2019
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. | 80 |
U | Unclassified | 2 |