Primary Device ID | 06944413811522 |
NIH Device Record Key | 819472c6-afaf-4c62-89ed-533f4f8e8a22 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Diagnostic Ultrasound System |
Version Model Number | Acclarix AX25 |
Company DUNS | 529173163 |
Company Name | Edan Instruments, 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 | 06944413811522 [Primary] |
IYO | System, Imaging, Pulsed Echo, Ultrasonic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-12-17 |
Device Publish Date | 2019-12-09 |
06944413810723 | U60 |
06944413808867 | Acclarix AX4 |
06944413807037 | P10 |
06944413807020 | DUS-5000 |
06944413802575 | Acclarix LX8 |
06944413802544 | Acclarix LX7 |
06944413802315 | Acclarix AX7 |
06944413802285 | Acclarix AX8 |
06944413801721 | U2 |
06944413801714 | U50 |
06944413811584 | Acclarix AX18 |
06944413811560 | Acclarix AX15 |
06944413811546 | Acclarix AX28 |
06944413811522 | Acclarix AX25 |
06944413811508 | Acclarix AX2 Exp |
06944413811492 | Acclarix AX2 Super |
06944413811485 | Acclarix AX2 |
06944413811478 | Acclarix AX3 Exp |
06944413811461 | Acclarix AX3 Super |
06944413811454 | Acclarix AX3 |
06944413813342 | Acclarix LX28 |
06944413813328 | Acclarix LX25 |
06944413813311 | Acclarix LX3 Exp |
06944413813304 | Acclarix LX3 Super |
06944413813298 | Acclarix LX3 |