Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780439936
• Version / Model: MH19-318
• Catalog Number: MH19-318
• 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: 5
• Public Version Date: 2023-04-26
• Public Version Status: Update
• Public Device Record Key: b4402d3b-dcd6-41c5-8c38-94f1518fca2b

Device Description

Integra® Miltex® Billeau Ear Loop 6-1/2, Large, Size 3: 5.5mm wide, Flexible

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
JYQ	LOOP, WIRE	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31020	Ear snare	A hand-held manual surgical instrument intended to be inserted through the outer ear canal or through a surgical incision in the ear to remove tissue, typically tumorous or damaged tissue, from the ear during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834MH193180	HIBCC
Primary	10381780439936	GS1

Customer Contacts

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