AccessGUDID - DEVICE: Patient-Fitted TMJ Reconstructive Prosthesis System (B004YYMMDDNNNNRF0)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: B004YYMMDDNNNNRF0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 035877922 *Terms of Use

Device Description: Right Fossa Component

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):	Yes
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?
36042	Total temporomandibular joint prosthesis	A sterile artificial substitute for the temporomandibular joint (TMJ) implanted to treat patients with osteoarthritis, rheumatoid arthritis, congenital malformations, or neoplasms of the joint, as well as after trauma (e.g., fracture). It consists of mandibular condyle and mandibular fossa components implanted to functionally reconstruct the TMJ in the jaw. It is typically made of metal and/or polymeric materials. Fixation devices for implantation (e.g., screws) may be included.	Active	true

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: Yes
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: b01caf67-9fd9-4962-80a9-a54805bf0326
Public Version Date: November 18, 2021
Public Version Number: 1
DI Record Publish Date: November 10, 2021