| Primary Device ID | 00841517100490 |
| NIH Device Record Key | 359046c1-973f-433d-91be-faa0dc05db5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | P10x/8-4 MHz |
| Version Model Number | P07696-70A |
| 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 Temperature | Between -35 Degrees Celsius and 65 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841517100490 [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 | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-13 |
| 00841517105044 | Diagnostic Ultrasound Transducer |
| 00841517104894 | Diagnostic Ultrasound Transducer |
| 00841517102920 | Diagnostic Ultrasound Transducer |
| 00841517100490 | Diagnostic Ultrasound Transducer |
| 00841517100483 | Diagnostic Ultrasound Transducer |
| 00841517106911 | Diagnostic Ultrasound Transducer |
| 00841517107505 | Diagnostic Ultrasound Transducer |
| 00841517108960 | Diagnostic Ultrasound Transducer |
| 00841517110529 | Diagnostic Ultrasound Transducer |