Iontophor®-II

Basic Information

• Brand Name: Iontophor®-II
• Primary DI: 00702173155920
• Version / Model: 6111PM/DX
• Company Name: WR MEDICAL ELECTRONICS CO INC
• Labeler DUNS: 006196604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5d056d7f-0b30-4c8b-83d9-1240afb541ed

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	890.5525	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46303	Drug-delivery iontophoresis system generator	A battery-powered, portable device that may be used as an alternative to injections to transport ionic-solution medication through the movement of ions resulting from an applied electric field, to locally administer the medication transcutaneously. It supplies a constant direct current (e.g., 0.5 to 4 milliampere (mA) through a delivery electrode attached to the skin surface, and to which is typically attached a small reservoir containing a buffering agent and the medication (e.g., a corticosteroid or anaesthetic). A buffering agent return electrode completes the circuit. The reusable device typically includes setting controls and a display.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00702173155920	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K863166	000
K871869	000