Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780438182
• Version / Model: 70-184
• Catalog Number: 70-184
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-24
• Public Version: 7
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: 337fa35f-6c7b-4e6b-896e-5a5225a2c706

Device Description

Integra® Miltex® Plastic Filling Instrument 6-1/2", No. 5, Double Ended, Octagonal Handle

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
EIY	INSTRUMENT, FILLING, PLASTIC, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65077	Dental restoration carver, multiple-material	A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in multiple dental restoration materials such as amalgam, cement, and acrylic or composite resin/plastic (i.e., not dedicated to a particular material) by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It is typically a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834701840	HIBCC
Primary	10381780438182	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6-1/2"