| Primary Device ID | 00815440021573 |
| NIH Device Record Key | 4bfd182c-1b7e-4c7f-9bd6-5374d141ac5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Senhance Ultrasonic |
| Version Model Number | X9007620 |
| Catalog Number | 300-11011 |
| Company DUNS | 969118900 |
| Company Name | TRANSENTERIX, 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 | 00815440021573 [Primary] |
| NAY | System, Surgical, Computer Controlled Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00815440021573]
Moist Heat or Steam Sterilization
[00815440021573]
Moist Heat or Steam Sterilization
[00815440021573]
Moist Heat or Steam Sterilization
[00815440021573]
Moist Heat or Steam Sterilization
[00815440021573]
Moist Heat or Steam Sterilization
[00815440021573]
Moist Heat or Steam Sterilization
[00815440021573]
Moist Heat or Steam Sterilization
[00815440021573]
Moist Heat or Steam Sterilization
[00815440021573]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-07 |
| Device Publish Date | 2019-02-04 |
| 00815440021597 | Senhance Ultrasonic Footswitch |
| 00815440021580 | Senhance Ultrasonic Generator |
| 00815440021573 | Senhance Ultrasonic Transducer |
| 00815440021566 | Senhance Ultrasonic Dissector |
| 00815440021122 | Adapter, Senhance Ultrasonic |