Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780479765
• Version / Model: 012-14902
• Catalog Number: 012-14902
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2018-07-03
• Public Version: 3
• Public Version Date: 2020-07-02
• Public Version Status: Update
• Public Device Record Key: 717e9e75-10c8-406a-8317-6beb7fdbed5d
• Distribution End Date: 2020-03-31

Device Description

Onyx-Flex™ Spreaders MF 25mm

Device Characteristics

• Single Use: No
• 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: Yes
• 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
EKK	SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17890	Endodontic filling material condenser	A dental instrument that uses heat to condense an endodontic filling material in a root canal, in the axial/lateral direction. The working part is typically cylindrical or tapered, and circular in cross-section. A condenser is commonly used to function as a plugger or spreader. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834012149021	HIBCC
Primary	10381780479765	GS1
Unit of Use	00381780479768	GS1

Customer Contacts

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