Primary Device ID | 00814848020829 |
NIH Device Record Key | caceb239-2d3c-4e1d-83e0-b84c1d77fd88 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 16ch Flex SPEEDER Large 1.5T |
Version Model Number | Q7000247 |
Company DUNS | 614760119 |
Company Name | QUALITY ELECTRODYNAMICS LLC |
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 | 00814848020829 [Primary] |
MOS | Coil, Magnetic Resonance, Specialty |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-28 |
Device Publish Date | 2025-05-20 |
00814848020812 - 16ch Flex SPEEDER Medium 1.5T | 2025-05-28 |
00814848020829 - 16ch Flex SPEEDER Large 1.5T | 2025-05-28 |
00814848020829 - 16ch Flex SPEEDER Large 1.5T | 2025-05-28 |
00814848020775 - SureWave Elastography | 2025-04-21 |
00814848020799 - Contour Shoulder | 2025-04-11 |
00814848020782 - 16ch T/R Hand Wrist Coil | 2024-07-26 |
00814848020508 - Shape Coil | 2021-08-30 |
00814848020546 - Shape Coil | 2021-08-30 |
00814848020515 - 2Tx 28Rx Knee Coil | 2021-02-22 |