Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780424932
• Version / Model: 23-1060
• Catalog Number: 23-1060
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-12
• Public Version: 4
• Public Version Date: 2023-04-27
• Public Version Status: Update
• Public Device Record Key: 78b445b0-4c74-45e5-b6a3-9e2fd7cdabe6

Device Description

Integra® Miltex® Jackson Tracheal Bistoury 7", Curved Blade

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
KCC	BISTOURY, TRACHEAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35782	Tracheal bistoury	A surgical instrument in the form of a long, narrow-bladed knife designed for opening abscesses or slitting up sinuses and/or fistulas in the trachea. It is typically made of high-grade stainless steel and has a straight or curved cutting edge that terminates at the distal end with a sharp or blunt point. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H8342310600	HIBCC
Primary	10381780424932	GS1

Customer Contacts

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