| Primary Device ID | 06971679947016 |
| NIH Device Record Key | 2467c9ea-75e5-49b5-b466-2c54ed06fc6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Imaging Probe |
| Version Model Number | FT-3.5R65 |
| Company DUNS | 544348534 |
| Company Name | Wuxi Hisky Medical Technologies Co.,Ltd. |
| 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 | +8651085387702 |
| service@hiskymedical.com |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06971679947016 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-08 |
| Device Publish Date | 2020-03-31 |
| 06971679949065 - Shear Wave Quantificational Ultrasound Diagnostic System | 2023-02-16 |
| 06971679949072 - Shear Wave Quantificational Ultrasound Diagnostic System | 2023-02-16 |
| 06971679945005 - Shear Wave Quantificational Ultrasound Diagnostic System | 2020-04-08 |
| 06971679947016 - Imaging Probe | 2020-04-08 |
| 06971679947016 - Imaging Probe | 2020-04-08 |
| 06971679947023 - Fibrosis Scanning Probe | 2020-04-08 |