Duns Number:114773653
Device Description: Men's Liberty Acute without CathGrip
Catalog Number
-
Brand Name
Men's Liberty Acute
Version/Model Number
BIO210268
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
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
-
Product Code
NOA
Product Code Name
Device, Paste-On For Incontinence, Non-Sterile
Public Device Record Key
7d2be960-cd23-42d9-a2b8-f1a04155c17f
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 02, 2020
Package DI Number
10653599000875
Quantity per Package
35
Contains DI Package
00653599000878
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 84 |