Primary Device ID | 00840682100090 |
NIH Device Record Key | a587860a-f6a4-4d27-9efe-bbab7ee3d182 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Invenia |
Version Model Number | ABUS Review Software |
Company DUNS | 078863378 |
Company Name | GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, 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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840682100090 [Primary] |
PAA | Automated breast ultrasound |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-06-05 |
Device Publish Date | 2016-01-29 |
00840682100090 | ABUS Review Software |
00840682141161 | ABUS 2.0 |
00840682141109 | ABUS Viewer |
00840682100038 | ABUS Workstation |
00840682100021 | ABUS Scan Station |
00840682100014 | ABUS System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INVENIA 85933561 4589769 Live/Registered |
General Electric Company 2013-05-16 |