Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780465607
• Version / Model: UEGP3-KB
• Catalog Number: UEGP3-KB
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-19
• Public Version: 3
• Public Version Date: 2020-10-28
• Public Version Status: Update
• Public Device Record Key: f49b29b3-ce51-4385-8fe5-2e0ee2f9324d
• Distribution End Date: 2020-03-31

Device Description

Spreader, GP3, Single End, Black-Blue, Tactile Tone™

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	H834UEGP3KB0	HIBCC
Primary	10381780465607	GS1

Customer Contacts

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