Duns Number:672044515
Device Description: LIFESTYLES STYLES COLLECTION VARIETY PACK (ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM, ULTR LIFESTYLES STYLES COLLECTION VARIETY PACK (ULTRA SENSITIVE, ULTRA SENSITIVE PLATINUM, ULTRA THIN)
Catalog Number
-
Brand Name
LIFESTYLES
Version/Model Number
0024
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
K163107,K941258,K163107,K941258,K163107,K941258,K163107,K941258
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
94a715fe-cb48-4df0-a36a-dde00df64e43
Public Version Date
July 21, 2022
Public Version Number
2
DI Record Publish Date
August 19, 2021
Package DI Number
10070907000240
Quantity per Package
6
Contains DI Package
00070907000243
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 |