Duns Number:832637081
Device Description: PLATE BENDERS W/O SPRING FOR MATRIXMIDFACE
Catalog Number
SD03503038
Brand Name
MatrixMIDFACE
Version/Model Number
SD03.503.038
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 28, 2020
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
-
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
HXP
Product Code Name
INSTRUMENT, BENDING OR CONTOURING
Public Device Record Key
fccc3580-44d2-441d-bdf6-78939b1717fe
Public Version Date
June 29, 2020
Public Version Number
4
DI Record Publish Date
December 31, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
| 3 | A medical device with high risk that requires premarket approval | 30 |
| U | Unclassified | 1 |