Primary Device ID | 00195278718136 |
NIH Device Record Key | 850d0407-28ad-4c37-b390-ec56ba5774e5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Revolution |
Version Model Number | Ascend Plus |
Catalog Number | RevolutionAscendPlus |
Company DUNS | 696021596 |
Company Name | GE HEALTHCARE JAPAN CORPORATION |
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 | 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 | 00195278718136 [Primary] |
JAK | System, x-ray, tomography, computed |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-03 |
Device Publish Date | 2024-04-25 |
00840682109796 | EVO |
00840682146173 | NGX Gantry common top asm with UDI |
00195278718204 | Ascend Select Gantry common top asm with UDI |
00195278718136 | Ascend Plus Gantry common top asm with UDI |
00195278718129 | Ascend Elite Gantry common top asm with UDI |