Duns Number:035877922
Device Description: Left Mandibular Component
Catalog Number
-
Brand Name
Patient-Fitted TMJ Reconstructive Prosthesis System
Version/Model Number
TYY-NNNNLM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
LZD
Product Code Name
Joint, Temporomandibular, Implant
Public Device Record Key
12a0d58e-8d0e-4cde-8826-a810b0379533
Public Version Date
April 19, 2022
Public Version Number
5
DI Record Publish Date
January 27, 2017
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 | 13 |
3 | A medical device with high risk that requires premarket approval | 23 |