Duns Number:372587696
Device Description: Partially Absorbable Hernia Repair Device
Catalog Number
UPLUG553
Brand Name
ULTRAPRO COMFORT PLUG
Version/Model Number
UPLUG553
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"
-
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
983bd43c-fb55-47ed-9e44-431e66a66f63
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2019
Package DI Number
20705031228471
Quantity per Package
3
Contains DI Package
10705031228474
Package Discontinue Date
-
Package Status
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 |