Primary Device ID | B36711001L00 |
NIH Device Record Key | 805dd9b1-edca-4758-8e72-b228ed457ef0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EMPI Focus 2 Channel Stimulator |
Version Model Number | 0 |
Catalog Number | 11001 |
Company DUNS | 033139835 |
Company Name | AXIOBIONICS |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B36711001L00 [Primary] |
GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-10-23 |
Device Publish Date | 2016-09-24 |
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B367145M00 - Spectra 360 Electrode Gel | 2018-10-22 Electrode Gel Monthly Supply (4 8 oz tubes) |