Iontophor®-II
GUDID 00702173155920
WR MEDICAL ELECTRONICS CO INC
Drug-delivery iontophoresis system generator| Primary Device ID | 00702173155920 |
| NIH Device Record Key | 5d056d7f-0b30-4c8b-83d9-1240afb541ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Iontophor®-II |
| Version Model Number | 6111PM/DX |
| Company DUNS | 006196604 |
| Company Name | WR MEDICAL ELECTRONICS CO INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 651-604-8400 |
| info@wrmed.com | |
| Phone | 651-604-8400 |
| info@wrmed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00702173155920 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K863166
FDA Product Code
| EGJ | Device, Iontophoresis, Other Uses |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-21 |
Devices Manufactured by WR MEDICAL ELECTRONICS CO INC
| 00702173122755 - Therabath | 2020-03-19 |
| 00702173122809 - Therabath | 2019-11-14 |
| 00702173139005 - Hilger Dual Stim | 2018-07-06 |
| 00702173139050 - Hilger Dual-Stimulator Remote Probe | 2018-07-06 |
| 00702173151885 - Q-Sweat | 2018-07-06 |
| 00702173151915 - Meridian™ Iontophoretic Drug Delivery Electrode | 2018-07-06 |
| 00702173152929 - Meridian™ Iontophoretic Drug Delivery Electrode | 2018-07-06 |
| 00702173155920 - Iontophor®-II | 2018-07-06 |
| 00702173155920 - Iontophor®-II | 2018-07-06 |
Trademark Results [Iontophor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IONTOPHOR 86106925 4894102 Live/Registered |
WR MEDICAL ELECTRONICS CO. 2013-10-31 |
 IONTOPHOR 74270742 1743002 Dead/Cancelled |
WR MEDICAL ELECTRONICS CO. 1992-04-30 |
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