Duns Number:114773653
Device Description: Men's Liberty Acute with CathGrip and Towel
Catalog Number
-
Brand Name
Men's Liberty Acute
Version/Model Number
BIO2102611
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
f1a00ed4-fe3d-4f5d-a7e5-0c3ee0df035f
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 06, 2020
Package DI Number
10653599000851
Quantity per Package
35
Contains DI Package
00653599000854
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 |