AccessGUDID - DEVICE: Patient-Fitted TMJ Reconstructive Prosthesis System (B004YYMMDDNNNNM0)

GUDID

Device Identifier (DI) Information

Brand Name: Patient-Fitted TMJ Reconstructive Prosthesis System
Version or Model: YYMMDDNNNNM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TMJ Solutions, Inc.

Primary DI Number: B004YYMMDDNNNNM0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 035877922 *Terms of Use

Device Description: Anatomical Bone Model

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62215	Custom-made organ/bone anatomy model	A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZD	Joint, Temporomandibular, Implant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980052	007

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 774452bc-4432-4de8-a9a4-2ef8704a8253
Public Version Date: August 20, 2024
Public Version Number: 2
DI Record Publish Date: November 10, 2021