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GUDID 00815440021924
Olympus ENDOEYE 3D 10 mm Endoscope Adapter
Asensus Surgical, Inc.
Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system| Primary Device ID | 00815440021924 |
| NIH Device Record Key | b22e5f38-6aad-4a07-9fc1-a6d7005b91a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Senhance |
| Version Model Number | X9007680 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815440021924 [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 |
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
[00815440021924]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-27 |
| Device Publish Date | 2023-09-19 |
On-Brand Devices [Senhance]
| 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 |
Trademark Results [Senhance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENHANCE 86953495 not registered Live/Pending |
Transenterix Surgical, Inc. 2016-03-25 |
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