Primary Device ID | 00195278788665 |
NIH Device Record Key | 87b44488-3474-4839-bdcb-b31d62c9a030 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Revolution Apex |
Version Model Number | Select with Plus Edition |
Catalog Number | B7919YO |
Company DUNS | 654659689 |
Company Name | Hangwei GE Medical Systems Co., Ltd. |
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 | 00195278788665 [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 | 2024-01-03 |
Device Publish Date | 2023-12-26 |
00195278913807 - Definium | 2024-11-07 Definium Pace Select ET System UDI |
00195278832252 - NA | 2024-07-09 Galaxy 2.0 Wall Stand(Insert Left) |
00195278798107 - Revolution | 2024-03-07 Revolution Ascend Sliding designated medical device |
00195278788665 - Revolution Apex | 2024-01-03Revolution Apex Select with Plus Edition - Designated System Medical Device |
00195278788665 - Revolution Apex | 2024-01-03 Revolution Apex Select with Plus Edition - Designated System Medical Device |
00195278526892 - Definium | 2023-09-26 Definium Pace Select system designated medical device |
00195278713759 - NA | 2023-09-26 Galaxy 2.0 Wall Stand |
00195278713766 - NA | 2023-09-26 Value Fixed Table |
00195278686718 - Revolution | 2023-06-30 Revolution Maxima CT designated medical device |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
REVOLUTION APEX 87586210 not registered Live/Pending |
General Electric Company 2017-08-28 |