Duns Number:001211952
Device Description: Trojan Pack contains Double Ecstasy, Ultra Thin, Fire & Ice, Ultra Ribbed and Her Pleasure Trojan Pack contains Double Ecstasy, Ultra Thin, Fire & Ice, Ultra Ribbed and Her Pleasure Sensations
Catalog Number
-
Brand Name
Trojan™ Pleasure Pack
Version/Model Number
00022600002291
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
K120286,K120287,K901192,K901194,K120286,K120287,K901192,K901194
Product Code
HIS
Product Code Name
CONDOM
Public Device Record Key
42958f79-56a5-4a78-9c22-3fe93e15ad97
Public Version Date
April 29, 2019
Public Version Number
1
DI Record Publish Date
April 19, 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 |