AccessGUDID - DEVICE: Stock TMJ Fossa-Eminence Prosthesis (LEFT 38) (M9575000380)

GUDID

Device Identifier (DI) Information

Brand Name: Stock TMJ Fossa-Eminence Prosthesis (LEFT 38)
Version or Model: 500038
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Nexus Cmf, L.L.C.

Primary DI Number: M9575000380
Issuing Agency: HIBCC
Commercial Distribution End Date: May 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 965540227 *Terms of Use

Device Description: Stock TMJ Fossa-Eminence Prosthesis (LEFT 38)

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":	No
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?
55825	Mandibular fossa prosthesis	A sterile implantable component of a total temporomandibular joint (TMJ) prosthesis designed to replace or repair the articulating surface of the joint comprised of the glenoid fossa and the articulating eminence of the temporal bone. It is cup-like in shape and typically made of polyethylene (PE); it may include screws for attachment to temporal bone.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MPI	Glenoid Fossa Prosthesis
LZD	Joint, Temporomandibular, Implant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 89ec0603-dfe8-4cf2-85df-d64f69536939
Public Version Date: November 25, 2020
Public Version Number: 5
DI Record Publish Date: November 11, 2014