Primary Device ID | 00628678950016 |
NIH Device Record Key | a7aa6e42-3bd0-494c-85b5-13ff7844eccd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | densitas® densityAI™ |
Version Model Number | 2.x.y |
Company DUNS | 204371579 |
Company Name | Densitas Incorporated |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00628678950016 [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 | 2022-05-11 |
Device Publish Date | 2022-05-03 |
10627843712777 | densitas® densityai™ 2.6.2 |
00628678950016 | Version 2.7.0 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DENSITAS 87979037 not registered Live/Pending |
Densitas, Inc. 2017-05-12 |
DENSITAS 87447865 not registered Live/Pending |
Densitas, Inc. 2017-05-12 |
DENSITAS 86379034 not registered Dead/Abandoned |
Densitas Inc. 2014-08-27 |