Primary Device ID | 00840682146197 |
NIH Device Record Key | b5736d77-c980-4e14-b45c-e37c725a676d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Revolution |
Version Model Number | ACT LMB |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840682146197 [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 | 2019-08-02 |
Device Publish Date | 2019-07-25 |
00840682146180 | Maxima |
00840682146159 | Ace |
00840682146197 | ACT LMB |
00840682137553 | Frontier |
00840682135313 | ACT |
00840682147392 | Revolution Maxima CT designated medical device, WSO make |
00195278403087 | Revolution Eagle designated medical device |
00195278385215 | Revolution Advance designated medical device |
00195278469700 | Revolution Apex Select - Designated System Medical Device |
00195278362247 | Revolution Frontier ES for EOL CT Designated medical device |
00195278362230 | Revolution Frontier for EOL CT Designated medical device |
00195278686718 | Revolution Maxima CT designated medical device |
00195278798107 | Revolution Ascend Sliding designated medical device |