Duns Number:776742439
Device Description: The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anter The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.
Catalog Number
-
Brand Name
4DDOME®
Version/Model Number
4DDOM24GSR
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
K070918
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
29648d74-015c-4ad7-a63f-954fa35c411a
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
October 23, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |