Primary Device ID | 00840682123242 |
NIH Device Record Key | 3fe3ba08-b7a6-46be-87c8-c15aa5105562 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Senographe Essential |
Version Model Number | ES14 |
Company DUNS | 266062561 |
Company Name | GE MEDICAL SYSTEMS |
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 | true |
OTC Over-The-Counter | false |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840682123242 [Primary] |
MUE | Full field digital,system,x-ray,mammographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-12-29 |
00195278866899 - not applicable | 2024-06-17 Software Pristina 8.4 - ISO file |
00195278719812 - not applicable | 2024-04-19 Software Pristina ME 9.2 - ISO file |
00195278534064 - Spine Auto Views | 2024-03-19 Spine Auto Views Medical Device |
00195278795724 - not applicable | 2024-01-30 Software Pristina 8.3 - ISO file |
00195278719263 - Allia | 2023-12-18 Allia IGS5 UDI |
00195278719577 - Allia | 2023-12-18 Allia IGS3 UDI |
00195278719720 - Allia | 2023-12-18 Allia IGS 7 UDI |
00195278719744 - Allia | 2023-12-18 Allia IGS 7 OR UDI |