Duns Number:046189866
Device Description: 55 MM RIGHT STANDARD MANDIBULAR COMPONENT
Catalog Number
24-6555
Brand Name
TMJ SYSTEM
Version/Model Number
24-6555
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
P020016,P020016
Product Code
LZD
Product Code Name
Joint, Temporomandibular, Implant
Public Device Record Key
1c226edc-f1cf-4325-9c70-04ce64750c5e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2014
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 | 1783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11874 |
| 3 | A medical device with high risk that requires premarket approval | 34 |