Duns Number:001191048
Device Description: 3DMax™ MID Anatomical Mesh, Medium, Left, 3" x 5", 8 x 13 cm
Catalog Number
0116310
Brand Name
3DMax™ MID Anatomical Mesh
Version/Model Number
0116310
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
K200818
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
2769b361-eb31-470a-a4c4-a498b48ae3b4
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
July 27, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |