Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780152323
• Version / Model: 2616
• Catalog Number: 26-16
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-03
• Public Version: 6
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: cd7e751d-e73a-4ea7-9080-16c3f6a16306

Device Description

Integra® Miltex® McKenzie Perforator Drill, 13mm diameter

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: No
• 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
HBG	DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)	Neurology	882.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42981	Trephining power tool attachment	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to function as a craniotome when an appropriate cutter is inserted. It is inserted through a pre-drilled bur hole or perforator hole and is used to cut a flap in the bone of the skull vault (calvarium). It includes a small shielding tip at the distal end to prevent the end of the cutter penetrating the dura mater membrane. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H83426161	HIBCC
Primary	10381780152323	GS1

Customer Contacts

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