Duns Number:137258252
Device Description: Incisional Matrix 4 x 15 cm
Catalog Number
LRM0415
Brand Name
Gentrix®
Version/Model Number
LRM0415
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2020
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
K040621
Product Code
FTM
Product Code Name
Mesh, surgical
Public Device Record Key
a36a96c2-ccbf-4395-b410-441e6055ebff
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
January 19, 2018
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. | 91 |
U | Unclassified | 62 |