Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780507284
• Version / Model: DP1030-3
• Catalog Number: DP1030-3
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 216
• Record Status: Published
• Publish Date: 2018-09-12
• Public Version: 5
• Public Version Date: 2023-04-27
• Public Version Status: Update
• Public Device Record Key: cbfce0fe-893e-47ac-abd0-abaaac05f939

Device Description

Integra® Miltex® DenLite® Disposable Mirrors, REF#'s DP1000, DP1500, 3 Boxes-72 each, 216 per Case

Device Characteristics

• Single Use: Yes
• 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
EAX	MIRROR, MOUTH	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64029	Dental mirror, single-use	A sterile, hand-held dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834DP103031	HIBCC
Primary	10381780507284	GS1
Unit of Use	00381780507287	GS1

Customer Contacts

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