Patient-Specific TMJ Fossa-Eminence Trial Sizer (LEFT SIDE)

GUDID M9575001070

Patient-Specific TMJ Fossa-Eminence Trial Sizer (LEFT SIDE)

Nexus Cmf, LLC

Mandibular fossa prosthesis

• Primary Device ID: M9575001070
• NIH Device Record Key: 2d1d4372-e857-4ba4-ae9f-6da88f75b9f5
• Commercial Distribution Discontinuation: 2017-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Patient-Specific TMJ Fossa-Eminence Trial Sizer (LEFT SIDE)
• Version Model Number: 500107
• Company DUNS: 965559623
• Company Name: Nexus Cmf, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9575001070 [Primary]

FDA Product Code

• LZD: Joint, Temporomandibular, Implant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-19
• Device Publish Date: 2014-10-15

Devices Manufactured by Nexus Cmf, LLC

• M9575000010 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 01): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 01)
• M9575000030 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 03): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 03)
• M9575000040 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 04): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 04)
• M9575000050 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 05): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 05)
• M9575000060 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 06): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 06)
• M9575000080 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 08): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 08)
• M9575000100 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 10): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 10)
• M9575000130 - Stock TMJ Fossa-Eminence Prosthesis (LEFT 13): 2020-10-27 Stock TMJ Fossa-Eminence Prosthesis (LEFT 13)