Primary Device ID | 00864366000124 |
NIH Device Record Key | f5ca1d4e-e4ec-462c-bfeb-172b0bd47675 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MEVION S250i |
Version Model Number | S250i |
Catalog Number | MEVION S250i |
Company DUNS | 199652145 |
Company Name | MEVION MEDICAL SYSTEMS, INC. |
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 |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00864366000124 [Primary] |
LHN | System, Radiation Therapy, Charged-Particle, Medical |
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 | 2018-02-05 |
00864366000100 - Mevion Medical Systems | 2018-07-06 Proton Beam Radiation Therapy System |
00864366000124 - MEVION S250i | 2018-07-06 |
00864366000124 - MEVION S250i | 2018-07-06 |