Duns Number:175752724
Device Description: Natural rubber latex condom, lubricated, thin
Catalog Number
04036
Brand Name
004® ZERO ZERO FOUR® CONDOMS
Version/Model Number
04036
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
-
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
97d3d6a5-46c3-4f75-bd7d-21453c48916b
Public Version Date
January 07, 2019
Public Version Number
1
DI Record Publish Date
December 07, 2018
Package DI Number
10028373040369
Quantity per Package
24
Contains DI Package
00028373040362
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |