Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780462293
• Version / Model: 15061
• Catalog Number: 15061
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-22
• Public Version: 3
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: b9ec561b-c331-41fb-8279-c9a95bd50f1b

Device Description

Integra® Miltex® LED Loupes Light Filter, Flip-Up, For Use with Dental Composite

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HJH	Loupe, binocular, low power	Ophthalmic	886.5120	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32692	Surgical binoculars, reusable	A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834150610	HIBCC
Primary	10381780462293	GS1

Customer Contacts

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