Patient-Fitted TMJ Reconstructive Prosthesis System - Left Mandibular Component - TMJ Solutions, Inc.

Duns Number:035877922

Device Description: Left Mandibular Component

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More Product Details

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

Product Characteristics

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 Details

Product Code

LZD

Product Code Name

Joint, Temporomandibular, Implant

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TMJ SOLUTIONS, INC." Characteristics
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