| Primary Device ID | 00841517100162 |
| NIH Device Record Key | d9d13159-8ccf-44dc-87c3-64e3f5dab2d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AxoTrack I Sterile Procedure Kit |
| Version Model Number | P22508-02 |
| Catalog Number | P22508 |
| Company DUNS | 014438860 |
| Company Name | FUJIFILM SONOSITE, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-877-657-8118 |
| ffss-service@fujifilm.com |
| Needle Gauge | 21 Gauge |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841517100162 [Primary] |
| GS1 | 30841517100163 [Package] Package: case [10 Units] In Commercial Distribution |
| IYO | System, imaging, pulsed echo, ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-10 |
| 30841517100156 | Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultras |
| 00841517100162 | Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultras |