Duns Number:123853058
Device Description: Titanium Ridge Augmentation Mesh, 25mm x 34mm, Nonsterile, Contents: 1 Mesh
Catalog Number
-
Brand Name
OSTEO-MESH TM-300
Version/Model Number
TM2534
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
JEY
Product Code Name
Plate, Bone
Public Device Record Key
00f10bc8-6dda-4f1b-81a6-3f6f50497f80
Public Version Date
December 07, 2020
Public Version Number
4
DI Record Publish Date
April 29, 2016
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. | 226 |