Duns Number:372587696
Device Description: Polypropylene partially absorbable blue / undyed Mesh
Catalog Number
UMS3
Brand Name
ULTRAPRO
Version/Model Number
UMS3
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
24e26dfa-3cbe-4ac4-a5d4-f8a12621caf7
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2019
Package DI Number
20705031085944
Quantity per Package
3
Contains DI Package
10705031085947
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 |