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 |