Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780419334
• Version / Model: 19-246
• Catalog Number: 19-246
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-21
• Public Version: 3
• Public Version Date: 2020-02-05
• Public Version Status: Update
• Public Device Record Key: 489b76e6-71d0-4534-981d-92feff984fae

Device Description

Hartman Eustachian Catheter 5-5/8", Bulbous Tip, 3.5mm Diameter, Size 2

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
GBY	CATHETER, EUSTACHIAN, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42451	Eustachian catheter, reusable	A long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown from an external bag through the device and into the middle ear. It is typically made of soft metals [e.g., silver (Ag) coated brass], and has a curved distal end with a slightly bulbous tip and a wider funnel-like proximal end with a finger ring to aid manipulation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834192460	HIBCC
Primary	10381780419334	GS1

Customer Contacts

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