Duns Number:177056145
Device Description: Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53mm), Lubricated With Sil Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.
Catalog Number
-
Brand Name
CautionWear PPE
Version/Model Number
CW0001PPE
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,K002393,K002393,K002393,K002393,K002393,K002393
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
b757f568-b50b-42f4-a4b0-85aaf09ae4e5
Public Version Date
June 24, 2021
Public Version Number
4
DI Record Publish Date
February 20, 2017
Package DI Number
00850836007410
Quantity per Package
4
Contains DI Package
00850836007403
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 |