Duns Number:672044515
Device Description: LIFESTYLES KYNG 3S (LIFESTYLES KING 3CT)
Catalog Number
-
Brand Name
LIFESTYLES
Version/Model Number
9803
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
K001883,K941258,K001883,K941258,K001883,K941258
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
8c50f34c-2356-4382-921c-956724a6eac5
Public Version Date
August 27, 2019
Public Version Number
6
DI Record Publish Date
July 11, 2016
Package DI Number
10070907098032
Quantity per Package
6
Contains DI Package
00070907098035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 26 |