Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780479697
• Version / Model: 700006-4505-001
• Catalog Number: 700006-4505-001
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-07-03
• Public Version: 4
• Public Version Date: 2022-07-19
• Public Version Status: Update
• Public Device Record Key: 2c002342-31d9-437c-ae5a-4087bfc8aef2
• Distribution End Date: 2022-05-01

Device Description

Precision™ Drill - Size 5.5, for Parallel Sided Post Technique - 10 Pack

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
DZA	DRILL, DENTAL, INTRAORAL	Dental	872.4130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43311	Pin/post dental drill bit	A shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H83470000645050011	HIBCC
Primary	10381780479697	GS1
Unit of Use	00381780479690	GS1

Customer Contacts

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