Duns Number:177056145
Device Description: Male Latex Condom, Parallel-Sided, Smooth Texture, Large (56 mm), Lubricated With Silicon- Male Latex Condom, Parallel-Sided, Smooth Texture, Large (56 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.
Catalog Number
-
Brand Name
CautionWear Grande
Version/Model Number
CW0001GR
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
K012964,K012964,K012964,K012964,K012964,K012964,K012964,K012964
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
979f4710-f25d-4a25-a90a-03850e9e4b7c
Public Version Date
July 15, 2021
Public Version Number
6
DI Record Publish Date
October 11, 2017
Package DI Number
00850836007502
Quantity per Package
4000
Contains DI Package
00850836007472
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 |