Senhance 200-21066
GUDID 00815440020606
Adapter, Fundus Grasper, Long
TRANSENTERIX, INC.
Robotic surgical system| Primary Device ID | 00815440020606 |
| NIH Device Record Key | b5f5a150-1c0e-4bdb-9d54-c8c89c17e9bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Senhance |
| Version Model Number | X9007039 |
| Catalog Number | 200-21066 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815440020606 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171120
FDA Product Code
| NAY | System,Surgical,Computer Controlled Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
[00815440020606]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-11-27 |
On-Brand Devices [Senhance]
| 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 |
Trademark Results [Senhance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENHANCE 86953495 not registered Live/Pending |
Transenterix Surgical, Inc. 2016-03-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.