Primary Device ID | EKAV100879340 |
NIH Device Record Key | 2833d196-ac29-44a1-9768-90dfc50fa217 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DEXIS 10 (DEXIS Imaging Suite) |
Version Model Number | 10 |
Catalog Number | 1.008.7934 |
Company DUNS | 019717844 |
Company Name | DEXIS LLC |
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 | 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 |
---|---|
HIBCC | EKAV100879340 [Primary] |
LLZ | System, Image Processing, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-01-31 |
Device Publish Date | 2022-01-21 |
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EKAV100879340 - DEXIS 10 (DEXIS Imaging Suite) | 2022-01-31 |
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