| Primary Device ID | 00815440021153 | 
| NIH Device Record Key | 96731824-ca61-45cb-89ad-9ca5274a7477 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Senhance | 
| Version Model Number | X0007004 | 
| Catalog Number | 200-11082 | 
| 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 | true | 
| Serial Number | false | 
| 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 | 
| Outer Diameter | 5 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 240 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00815440021153 [Primary] | 
| NAY | System, Surgical, Computer Controlled Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
[00815440021153]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2018-12-03 | 
| Device Publish Date | 2018-11-02 | 
| 00815440021696 | Bipolar Curved Scissors | 
| 00815440021689 | Bipolar Maryland Dissector | 
| 00815440021672 | Bipolar Curved Grasping Forceps | 
| 00815440021665 | Bipolar Large Grasping Forceps | 
| 00815440021658 | Bipolar Shaft | 
| 00815440021498 | Adapter, Bipolar Curved Scissors | 
| 00815440021481 | Adapter, Bipolar Maryland Dissector | 
| 00815440021474 | Adapter, Bipolar Curved Grasping Forceps | 
| 00815440021467 | Adapter, Bipolar Large Grasping Forceps | 
| 00815440021429 | Adapter, Passive Weck® Hem-o-lok® ML Clip Applier | 
| 00815440021412 | Adapter, Passive Fundus Grasper | 
| 00815440021399 | Adapter, Monopolar Maryland Dissector | 
| 00815440021382 | Adapter, Monopolar Metzenbaum Scissors 15 mm Tip | 
| 00815440021375 | Adapter, Monopolar Metzenbaum Scissors 18 mm Tip | 
| 00815440021368 | Adapter, Passive Needle Holder Left | 
| 00815440021351 | Adapter, Passive Needle Holder Right | 
| 00815440021344 | Adapter, Passive Babcock Forceps | 
| 00815440021337 | Adapter, Passive Mixter Dissector | 
| 00815440021320 | Adapter, Passive Strong Grasper | 
| 00815440021313 | Adapter, Passive Johan Grasper 15 mm Tip | 
| 00815440021306 | Adapter, Passive Allis Grasper | 
| 00815440021283 | Weck® Hem-o-lok® ML Clip Applier | 
| 00815440021276 | Fundus Grasper | 
| 00815440021252 | Monopolar Maryland Dissector | 
| 00815440021245 | Monopolar Metzenbaum Scissors 15 mm Tip | 
| 00815440021238 | Monopolar Metzenbaum Scissors 18 mm Tip | 
| 00815440021221 | Needle Holder Left | 
| 00815440021214 | Needle Holder Right | 
| 00815440021207 | Babcock Forceps | 
| 00815440021191 | Mixter Dissector | 
| 00815440021184 | Strong Grasper | 
| 00815440021177 | Kocher Grasper | 
| 00815440021160 | Adapter, Passive Kocher Grasper | 
| 00815440021153 | Johan Grasper 15 mm Tip | 
| 00815440021146 | Allis Grasper | 
| 00815440021115 | Senhance System Power Pack (US) | 
| 00815440021108 | Senhance Manipulator Arm | 
| 00815440021092 | NOVADAQ 10 mm Endoscope Adapter | 
| 00815440021085 | NOVADAQ 5 mm Endoscope Adapter | 
| 00815440021078 | Stryker Advanced Imaging 5 mm Endoscope Adapter | 
| 00815440021061 | CONMED 3DHD 10 mm Endoscope Adapter | 
| 00815440020996 | Adapter, Passive Needle Holder Straight | 
| 00815440020965 | Adapter, Monopolar Curved Metzenbaum Scissors | 
| 00815440020941 | Adapter, Monopolar Maryland Dissector | 
| 00815440020927 | Adapter, Passive DeBakey Grasper | 
| 00815440020903 | Adapter, Passive Cobra Grasper | 
| 00815440020880 | Adapter, Passive Atraumatic Single Action Grasper | 
| 00815440020866 | Adapter, Bipolar Maryland Dissector | 
| 00815440020859 | Adapter, Bipolar Curved Scissors | 
| 00815440020842 | Adapter, Bipolar Curved Grasping Forceps | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SENHANCE  86953495  not registered Live/Pending | Transenterix Surgical, Inc. 2016-03-25 |