| Primary Device ID | 00841517100421 |
| NIH Device Record Key | b711f643-ea07-4c33-8516-4b959a353d9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ICTx/8-5 MHz |
| Version Model Number | P07690-71A |
| 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 | 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 |
| Phone | 1-877-657-8118 |
| ffss-service@fujifilm.com |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841517100421 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-23 |
| Device Publish Date | 2016-09-13 |
| 00841517105051 | Diagnostic Ultrasound Transducer |
| 00841517104849 | Diagnostic Ultrasound Transducer |
| 00841517103750 | Diagnostic Ultrasound Transducer |
| 00841517103743 | Diagnostic Ultrasound Transducer |
| 00841517102890 | Diagnostic Ultrasound Transducer |
| 00841517100803 | Diagnostic Ultrasound Transducer |
| 00841517100797 | Diagnostic Ultrasound Transducer |
| 00841517100421 | Diagnostic Ultrasound Transducer |
| 00841517100414 | Diagnostic Ultrasound Transducer |
| 00841517106287 | Diagnostic Ultrasound Transducer |
| 00841517106232 | Diagnostic Ultrasound Transducer |
| 00841517106935 | Diagnostic Ultrasound Transducer |
| 00841517107390 | Diagnostic Ultrasound Transducer |
| 00841517108939 | diagnostic Ultrasound transducer |
| 00841517110512 | Diagnostic Ultrasound Transducer |