Duns Number:675476406
Device Description: The SKORE Bulbous Dots & Ribs Natural is made of natural rubber latex.It is a bulbous teat The SKORE Bulbous Dots & Ribs Natural is made of natural rubber latex.It is a bulbous teat ended, fully textured, transparent male condom. It meets the requirements as specified in ASTM D 3492 standard for rubber latex contraceptives (Male condoms). The Skore bulbous dots and ribs natural rubber latex condoms are used for contraception and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases).
Catalog Number
-
Brand Name
SKORE BULBOUS DOTS AND RIBS
Version/Model Number
BULBOUS DOTS AND RIBS
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
K132490,K132490,K132490,K132490
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
274bc67d-5932-45a3-9dde-988bff825170
Public Version Date
August 15, 2018
Public Version Number
4
DI Record Publish Date
October 03, 2016
Package DI Number
08906007131735
Quantity per Package
2160
Contains DI Package
08906007131728
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-