NA

Basic Information

• Brand Name: NA
• Primary DI: 10887587016382
• Version / Model: 04.449.000
• Catalog Number: 04449000
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-14
• Public Version: 4
• Public Version Date: 2022-04-25
• Public Version Status: Update
• Public Device Record Key: 38c3049a-1e97-4fad-bfb8-db05ad1b2ee8

Device Description

TITANIUM CONDYLAR HEAD

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEI	Prosthesis, condyle, mandibular, temporary	Dental	872.4770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47930	Temporary mandibular condyle prosthesis	A sterile implantable device intended for the temporary reconstruction of the mandibular condyle of the temporomandibular joint (TMJ) typically in a patient undergoing ablative surgery requiring the removal of the mandibular condyle. It is typically made of metal or synthetic material and includes the condyle head with an adjustable plate for attachment to the remaining natural mandible.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H980044490000	HIBCC
Primary	10887587016382	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K063181	000