Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780462989
• Version / Model: 11756590INT
• Catalog Number: 11756590INT
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-10-24
• Public Version: 3
• Public Version Date: 2022-08-03
• Public Version Status: Update
• Public Device Record Key: a59fab65-304b-4d56-bdc7-f78016cfbac0
• Distribution End Date: 2022-05-01

Device Description

Beauty Pink™ Wax, Hard Pink, 2.27kg (5 lb.)

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGD	WAX, DENTAL, INTRAORAL	Dental	872.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34807	Wax dental impression material	A material made of wax, sometimes in combination with resins of low melting point, designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H83411756590INT0	HIBCC
Primary	10381780462989	GS1
Unit of Use	00381780462982	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Temperature: 65°F (18°C) to 85°F (29°C)