| Primary Device ID | 00897826002055 |
| NIH Device Record Key | c2612c56-5417-43a8-a9f4-495096085ad5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accupach VI |
| Version Model Number | 24-6200 |
| Catalog Number | 24-6200 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00897826002055 [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 | 5 |
| Public Version Date | 2021-11-29 |
| Device Publish Date | 2016-09-13 |
| 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 |
| 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 |