Primary Device ID | 04582275270068 |
NIH Device Record Key | 4138f164-bfa4-4dd3-8c34-283d038f8670 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | COLORDX CCT HD |
Company DUNS | 788439219 |
Company Name | KONAN MEDICAL USA, 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 | false |
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 |