Duns Number:672044515
Device Description: LIFESTYLES PLEASURE COLLECTION 30CT- CONTAINS SKYN ELITE, SKYN ORIGINAL, ULTRA SENSITIVE P LIFESTYLES PLEASURE COLLECTION 30CT- CONTAINS SKYN ELITE, SKYN ORIGINAL, ULTRA SENSITIVE PLATINUM, ULTRA SENSITIVE AND FLAVORS & COLORS
Catalog Number
-
Brand Name
LIfestyles
Version/Model Number
2625
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)
-
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
3bf65a82-4499-4505-8786-e49321e28a4c
Public Version Date
October 11, 2021
Public Version Number
4
DI Record Publish Date
December 20, 2018
Package DI Number
30070907026251
Quantity per Package
6
Contains DI Package
10070907026257
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |