Duns Number:372587696
Device Description: Macroporous Partially Absorbable Mesh
Catalog Number
UPA31015
Brand Name
ULTRAPRO ADVANCED
Version/Model Number
UPA31015
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
dc786d75-78da-4c87-bcc4-40d8c431a05f
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
March 08, 2016
Package DI Number
20705031236995
Quantity per Package
3
Contains DI Package
10705031236998
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 |