Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780464587
• Version / Model: 11656450INT
• Catalog Number: 11656450INT
• 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: 2018-10-24
• Public Version: 3
• Public Version Date: 2022-07-18
• Public Version Status: Update
• Public Device Record Key: 0d55f159-aa63-48e3-96fb-cf8b2f14d662
• Distribution End Date: 2022-05-01

Device Description

Beauty Pink™ Wax, Soft Pink, 0.45kg (1 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	H83411656450INT0	HIBCC
Primary	10381780464587	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)