Duns Number:373139427
Device Description: TRUMATCH Midface/Mandible - Titanium 3D Printed Guide for Orbit
Catalog Number
SD980.104
Brand Name
TruMatch
Version/Model Number
SD980.104
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
K170272
Product Code
JEY
Product Code Name
Plate, Bone
Public Device Record Key
c228c880-41d1-4d28-b719-2a6170a542b5
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
March 16, 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 | 91 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 296 |