Duns Number:814851960
Device Description: Contraceptive, condom, maleBasic male condom, Hevea-latex A Hevea-latex rubber sheath inte Contraceptive, condom, maleBasic male condom, Hevea-latex A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device."
Catalog Number
-
Brand Name
PRUDENCE MIX C/12
Version/Model Number
Condom
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
K041837,K041837,K041837,K041837
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
6474eb9f-8185-4cec-9c67-0d0322208195
Public Version Date
January 29, 2020
Public Version Number
1
DI Record Publish Date
January 21, 2020
Package DI Number
00812420030204
Quantity per Package
12
Contains DI Package
00812420030259
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner