NEOFACE

Basic Information

• Brand Name: NEOFACE
• Primary DI: 07899893216130
• Version / Model: 901.300
• Company Name: Neoortho Produtos Ortopédicos S/A.
• Labeler DUNS: 914644351
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: da1a8a49-2c02-4a22-908b-a714de15147b

Device Description

Insertion Screw 2.0mm

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: Yes
• Has Expiration Date: Yes
• 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
DZL	Screw, Fixation, Intraosseous	Dental	872.4880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47749	Orthopaedic fixation plate bending insert, single-use	A non-sterile device that is inserted into the threaded or non-threaded hole of a metal orthopaedic fixation plate (e.g., trauma or craniofacial plate) prior to the surgeon bending the plate to conform to the anatomical shape of the implant site (e.g., jawbone or pelvis) in order to preserve the integrity of the holes which would otherwise deform, negating the entry of the bone screws that hold the plate in place. It is typically made of metal or synthetic material in the form of a short screw or pin-like device with a slotted head used solely during the bending of plates that typically have a continuous row of screw holes. This is a single-use device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07899893216130	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K102641	000