Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780418887
• Version / Model: 19-190
• Catalog Number: 19-190
• 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: 4
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: 40cc2d8e-04fd-4b16-8854-42324a392d15

Device Description

Integra® Miltex® Lathbury Cotton Applicator 5-1/2", Triangular Tip

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
KCJ	APPLICATOR, ENT	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33466	ENT powder applicator	An applicator designed to utilize blowing air, typically through the use of a hand-operated bulb, to administer powdered medication to the ear, nose, or oral cavity/throat during an ear/nose/throat (ENT) procedure or treatment. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834191900	HIBCC
Primary	10381780418887	GS1

Customer Contacts

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