Duns Number:372587696
Device Description: Partially Absorbable Hernia Repair Device
Catalog Number
UPLUG556
Brand Name
ULTRAPRO COMFORT PLUG
Version/Model Number
UPLUG556
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 22, 2020
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
66fa0f38-2acd-40b1-9c60-491cc9735e65
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
September 01, 2015
Package DI Number
20705031233291
Quantity per Package
6
Contains DI Package
10705031233294
Package Discontinue Date
May 22, 2020
Package Status
Not in Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 84 |