Primary Device ID | 00195278929518 |
NIH Device Record Key | be80a05a-dbeb-4a50-baff-f2b174beaf70 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | SIGNA Sprint |
Company DUNS | 421356265 |
Company Name | GE Medical Systems (Tianjin) 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 | 00195278929518 [Primary] |
LNH | System, Nuclear Magnetic Resonance Imaging |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-10-06 |
Device Publish Date | 2025-09-26 |
00195278929518 - NA | 2025-10-06SIGNA Sprint System Medical Device |
00195278929518 - NA | 2025-10-06 SIGNA Sprint System Medical Device |
00195278601162 - NA | 2025-04-23 SIGNA Prime Elite System Medical Device |
00195278707871 - NA | 2024-02-13 SIGNA Champion System Medical Device |
00195278629234 - NA | 2023-08-14 SIGNA Voyager 1.5T Detachable Table - Wireless Gating |
00195278616845 - NA | 2023-03-20 SIGNA Victor System Medical Device |
00195278481382 - NA | 2022-09-16 SIGNA Artist Evo System Medical Device, MDR |
00840682146302 - NA | 2022-03-15 SIGNA Prime System Medical Device |
00195278372307 - NA | 2021-06-23 Voyager AIR Medical Device Assembly |