Duns Number:114773653
Device Description: Faceplate Seal for iMEDicare (pack of 10)
Catalog Number
-
Brand Name
Men's Liberty
Version/Model Number
20002UK
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
58a9fdad-32c1-4883-8508-9b314b76b4a3
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
July 22, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 84 |