Duns Number:576342646
Device Description: Bilayer Mesh Monofilament Polypropylene
Catalog Number
DTN07RX3
Brand Name
Duatene
Version/Model Number
DTN07RX3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K172395,K172395
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
e2afc805-eb89-4a42-8b15-dc888335f70b
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
March 12, 2018
Package DI Number
20884521726595
Quantity per Package
3
Contains DI Package
10884521726598
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 239 |