Primary Device ID | 00857534006141 |
NIH Device Record Key | 949228a7-8f88-4f77-b614-eaf74ffb7546 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | iMRX System |
Version Model Number | ANTERIOR ASSY, 3T 16CH CARDIAC COIL |
Company DUNS | 079990922 |
Company Name | DEERFIELD IMAGING, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00857534006141 [Primary] |
IZI | System, X-Ray, Angiographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-11-04 |
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00857534006158 | iMRX System Post Assy, 1.5T 16CH Cardiac Coil,105856-000 |
00857534006141 | iMRX System ANTERIOR ASSY, 3T 16CH CARDIAC COIL, 105587-000 |
00857534006127 | iMRX System POSTERIOR ASSY, 3T 16CH CARDIAC COIL, 105589-000 |
00857534006110 | iMRX System Ant Assy, 1.5T 16CH Cardiac Coil, 105855-000 |