Primary Device ID | 04260308110108 |
NIH Device Record Key | aa6d528c-8134-4985-84f2-151f6054b50c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Prelude |
Version Model Number | V1. EBRT |
Company DUNS | 537689275 |
Company Name | MedCom Gesellschaft für medizinische Bildverarbeitung mbH |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04260308110108 [Primary] |
LHO | Instrument, Quality-Assurance, Radiologic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-13 |
Device Publish Date | 2022-10-05 |
04260308110108 | The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation trea |
04260308110092 | The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation trea |