| Primary Device ID | 00815440022235 | 
| NIH Device Record Key | 6faa5587-8f92-4354-a189-40be8ee7c412 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Senhance | 
| Version Model Number | X9007755 | 
| Company DUNS | 969118900 | 
| Company Name | Asensus Surgical, 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 | 00815440022235 [Primary] | 
| NAY | System, Surgical, Computer Controlled Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
[00815440022235]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-08-25 | 
| Device Publish Date | 2023-08-17 | 
| 00815440022280 | Karl Storz 3D4K 10mm Endoscope Adapter | 
| 00815440022259 | Articulating Instrument Coupler, Needle Driver | 
| 00815440022242 | Articulating Instrument Coupler, Atraumatic Grasper | 
| 00815440022235 | Articulating Instrument Adapter | 
| 00815440021856 | Senhance® Needle Driver, Articulating (US) | 
| 00815440021825 | Senhance® Bipolar Atraumatic Grasper, Articulating (US) | 
| 00815440021924 | Olympus ENDOEYE 3D 10 mm Endoscope Adapter | 
| 00815440022273 | KARL STORZ 4K 10 mm Endoscope Adapter | 
| 00815440022266 | KARL STORZ 4K 5 mm Endoscope Adapter | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SENHANCE  86953495  not registered Live/Pending | Transenterix Surgical, Inc. 2016-03-25 |