Primary Device ID | 00857869005093 |
NIH Device Record Key | 642c94b8-f1f1-40c0-a860-b3acd1726d8d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Alpha-Stim Earclip Electrode (CE3) |
Version Model Number | Earclip Electrode (CE3) |
Company DUNS | 610954729 |
Company Name | Electromedical Products International, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
Serial Number | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00857869005093 [Primary] |
JXK | Stimulator, Cranial Electrotherapy |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2014-08-25 |
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00857869005000 - Alpha-Stim M | 2019-05-23 Alpha-Stim M kit - China |
00857869005185 - Alpha-Stim PPM | 2019-05-23 Alpha-Stim PPM kit |
00857869005192 - Alpha-Stim 100 | 2019-05-23 Alpha-Stim 100 kit |