Duns Number:177056145
Device Description: Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53 mm), Lubricated With Si Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53 mm), Lubricated With Silicon Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.
Catalog Number
-
Brand Name
FPA
Version/Model Number
CU0001FPA
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
K002393,K002393
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
335edd33-e430-4ea1-9ad3-7166bb1ce905
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 10, 2016
Package DI Number
00850836007342
Quantity per Package
4000
Contains DI Package
00850836007335
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. | 1 |