Duns Number:001211952
Device Description: Pack contains:Trojan Double EcstasyTrojan Ultra ThinTrojan Fire & IceTrojan Ultra Ribbed P Pack contains:Trojan Double EcstasyTrojan Ultra ThinTrojan Fire & IceTrojan Ultra Ribbed Pre-76 ClearanceTrojan ENZ
Catalog Number
-
Brand Name
Trojan™ Premium Latex Condoms Pleasure Pack
Version/Model Number
00022600020165
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
-
Product Code
HIS
Product Code Name
CONDOM
Public Device Record Key
1804cde0-3f82-446d-a259-4322a6adb247
Public Version Date
November 30, 2018
Public Version Number
1
DI Record Publish Date
October 30, 2018
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 |