Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780419600
• Version / Model: 19-284
• Catalog Number: 19-284
• 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: 6
• Public Version Date: 2023-05-23
• Public Version Status: Update
• Public Device Record Key: 5010fce0-a332-4edc-92ae-ef89dd089177

Device Description

Integra® Miltex® Buck Ear Curette, Straight, Blunt, Size 1

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
JYG	CURETTE, EAR	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33450	Salpingeal curette	A slender, hand-held, surgical instrument that is used to clear blockages of the Eustachian tube during an ear/nose/throat (ENT) procedure. It is typically made of high-grade stainless steel and can be either rigid or malleable (bendable) and has a small, half-rounded, head terminating in a sharp scraping edge at its widest diameter at the curved distal end of a long shaft which has a handle at the proximal end. The scraping tip is available in various shapes and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834192840	HIBCC
Primary	10381780419600	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3	Millimeter
Device Size Text, specify			6-1/2"