MAGNETOM Sempra
GUDID 04056869044521
MRI Scanner
Siemens Shenzhen Magnetic Resonance Ltd.
Full-body MRI system, superconducting magnet| Primary Device ID | 04056869044521 |
| NIH Device Record Key | fda58664-f366-4456-abff-224672f75c07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAGNETOM Sempra |
| Version Model Number | 10840815 |
| Company DUNS | 544891302 |
| Company Name | Siemens Shenzhen Magnetic Resonance 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056869044521 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163211
FDA Product Code
| LNI | System, nuclear magnetic resonance spectroscopic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-07-17 |
| Device Publish Date | 2018-03-06 |
On-Brand Devices [MAGNETOM Sempra]
| 04056869044538 | MRI Scanner |
| 04056869044521 | MRI Scanner |
Trademark Results [MAGNETOM Sempra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAGNETOM SEMPRA 79253463 not registered Live/Pending |
Siemens Healthcare GmbH 2019-02-01 |
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