Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780168997
• Version / Model: 015-99613
• Catalog Number: 015-99613
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-09-12
• Public Version: 4
• Public Version Date: 2020-07-01
• Public Version Status: Update
• Public Device Record Key: 39f6cd1e-5304-4d09-8073-9a0c246d0389
• Distribution End Date: 2020-03-31

Device Description

Integrator™ Chiropractic Adjustment Instrument - Tips Only, Gray - 100 Pack

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
LXM	MANIPULATOR, PLUNGER-LIKE JOINT	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
63426	Joint/spinal manipulator, mechanical	A hand-held, non-electric, mechanically-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. The instrument uses a manually-operated, mechanical, plunger-like mechanism (e.g., spring-loaded) to deliver thrust to the patient's body via its rounded distal end (e.g., rubber-tipped stylus); it typically has two or more force settings. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834015996131	HIBCC
Primary	10381780168997	GS1
Unit of Use	00381780168990	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K950646	000