Primary Device ID | 00817613020154 |
NIH Device Record Key | 824e7473-73db-4d93-8780-1b957fa5cab8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EvolutionHD |
Version Model Number | P-EVO.1 |
Company DUNS | 051244569 |
Company Name | MED X CHANGE, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817613020154 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2018-02-23 |
00817613020352 | Mitaka EvolutionHD System, Rev 1 |
00817613020338 | Leica EvolutionHD System, Rev 1 |
00817613020239 | Leica EvolutionHD System, Rev 1 |
00817613020161 | EvolutionHD System, Rev 1 |
00817613020154 | Accessory Pack for the EvolutionHD, Rev 1 |
00817613020055 | Mitaka EvolutionHD System, Rev 1 |
00817613020048 | Inspire EvolutionHD System, Rev 1 |
00817613020031 | EvolutionHD System, Rev 1 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EVOLUTIONHD 85709162 4481955 Live/Registered |
Med X Change, Inc. 2012-08-21 |