Duns Number:672044515
Device Description: LIFESTYLES PLEASURE COLLECTION 36CT (CONTAINS: SKYN ELITE, SKYN ORIGINAL, ULTRA SENSITIVE LIFESTYLES PLEASURE COLLECTION 36CT (CONTAINS: SKYN ELITE, SKYN ORIGINAL, ULTRA SENSITIVE PLATINUM, ULTRA SENSITIVE AND ASSORTED FLAVORS)
Catalog Number
-
Brand Name
LIFESTYLES
Version/Model Number
3000
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
K000408,K160399,K163107,K941258,K000408,K160399,K163107,K941258,K000408,K160399,K163107,K941258,K000408,K160399,K163107,K941258
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
633051d7-d313-447b-92a1-d95f40cf0533
Public Version Date
September 06, 2019
Public Version Number
1
DI Record Publish Date
August 29, 2019
Package DI Number
30070907030005
Quantity per Package
6
Contains DI Package
10070907030001
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 |