Primary Device ID | 00815871021494 |
NIH Device Record Key | c5a24ba1-5c0a-4d3c-9772-89b983267ba4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | E-ST Pro |
Version Model Number | 60132PRO8 |
Company DUNS | 178440426 |
Company Name | Avante |
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 | true |
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 |
Phone | 502-244-4444 |
devicehelp@dremed.com | |
Phone | 502-244-4444 |
devicehelp@dremed.com | |
Phone | 502-244-4444 |
devicehelp@dremed.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815871021494 [Primary] |
HEP | Monitor, Blood-Flow, Ultrasonic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-06-19 |
Device Publish Date | 2016-09-23 |
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00815871020190 - Compact FM | 2020-03-02 |
00815871020206 - Compact FM | 2020-03-02 |
00815871020213 - Compact FM | 2020-03-02 |
00815871020220 - Compact FM | 2020-03-02 |
00815871020237 - Compact Plus | 2020-03-02 |
00815871020244 - Compact Plus | 2020-03-02 |
00815871020251 - Compact Plus | 2020-03-02 |