| Primary Device ID | 00897826002178 |
| NIH Device Record Key | 13522914-15a5-4447-b6bc-1b235632d154 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | B-scan Plus: Software Package |
| Version Model Number | 4.07.02-U |
| Company DUNS | 048792816 |
| Company Name | ACCUTOME, 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 | 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 | 00897826002178 [Primary] |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-11-29 |
| Device Publish Date | 2016-09-21 |
| 00897826002000 - Accupen | 2021-11-29 |
| 00897826002017 - Pachpen | 2021-11-29 |
| 00897826002024 - A-scan Plus Connect | 2021-11-29 |
| 00897826002031 - B-scan Plus | 2021-11-29 |
| 00897826002055 - Accupach VI | 2021-11-29 |
| 00897826002062 - B-scan Pro | 2021-11-29 |
| 00897826002079 - 4Sight | 2021-11-29 |
| 00897826002086 - AccuTip Cover | 2021-11-29 Individually wrapped |