Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780083085
• Version / Model: 3724058
• Catalog Number: 3724058
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-24
• Public Version: 4
• Public Version Date: 2023-04-17
• Public Version Status: Update
• Public Device Record Key: 46a45406-7e77-479f-b359-6f4e9683f95c

Device Description

Integra® House-Billeau Ear Loop, 6-1/2", 3.5mm Oval

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: Yes
• 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
47522	Endaural surgical curette, reusable	A slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780083085	GS1

Customer Contacts

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