Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780487333
• Version / Model: MH1-226
• Catalog Number: MH1-226
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-20
• Public Version: 3
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 8d511a61-c01d-402a-ab4d-631a4a55d2ae

Device Description

Integra® Miltex® Wartenberg Pin Wheel, 7-1/2"

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
GWY	PINWHEEL	Neurology	882.1750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47163	Pinwheel aesthesiometer	A manual stimulator designed to determine tactile sensibility by testing a patient's discrimination of diameter in rods mounted on a disc. It typically consists of a disc, with protruding rods that differ in diameter, mounted on a rotary pin; the disc is manually rotated on the patient's skin by moving an integral handle at the proximal end. The rods may be sharply pointed for testing pain sensation. The device is typically used during physical examinations for detecting peripheral neuropathy and/or in diabetes mellitus or leprosy diagnostics. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834MH12260	HIBCC
Primary	10381780487333	GS1

Customer Contacts

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