Duns Number:177056145
Device Description: Male Latex Condom, Studded, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Male Latex Condom, Studded, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Reservoir Tip, Lubricated With Ultra-Smooth Silicon-Based Lubricant
Catalog Number
-
Brand Name
CautionWear L.A.Confidential - Secret Passion
Version/Model Number
LAC0001SP
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
-
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
84fd2e48-4d72-453d-bead-d45eef3b2084
Public Version Date
June 28, 2021
Public Version Number
1
DI Record Publish Date
June 18, 2021
Package DI Number
00850836007687
Quantity per Package
24
Contains DI Package
00850836007069
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Plastic Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |