Duns Number:675476406
Device Description: The Sustain Natural Extra large Ribs and Dots is made of natural rubber latex. It is a bul The Sustain Natural Extra large Ribs and Dots is made of natural rubber latex. It is a bulbous teat ended, fully textured, transparentmale condom. it meets the requirements as specified in ASTM D3492 standard for rubber latex contraceptives (Male Condoms). TheSustain Natural Extra large Ribs and Dots natural rubber latex condoms are used for contraception and for prophylactic purposes (toHelp prevent pregnancy and the transmission of sexually transmitted diseases)
Catalog Number
-
Brand Name
Sustain Natural Extra Large Ribs and Dots.
Version/Model Number
Sustain Natural Extra Large Ribs and Dots
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,K132490,K132490,K132490,K132490,K132490
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
3a2b9806-c4b1-458e-80d1-40d9662566e6
Public Version Date
August 15, 2018
Public Version Number
3
DI Record Publish Date
May 10, 2018
Package DI Number
08906007132152
Quantity per Package
144
Contains DI Package
08906007132084
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box