Senhance

GUDID 00815440022259

Articulating Instrument Coupler, Needle Driver

Asensus Surgical, Inc.

Robotic surgical arm system
Primary Device ID00815440022259
NIH Device Record Key6393067a-ba8e-4f81-9ac5-7d5abdd5f61d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSenhance
Version Model NumberX9007759
Company DUNS969118900
Company NameAsensus Surgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815440022259 [Primary]

FDA Product Code

NAYSystem, Surgical, Computer Controlled Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


[00815440022259]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-25
Device Publish Date2023-08-17

On-Brand Devices [Senhance]

00815440022280Karl Storz 3D4K 10mm Endoscope Adapter
00815440022259Articulating Instrument Coupler, Needle Driver
00815440022242Articulating Instrument Coupler, Atraumatic Grasper
00815440022235Articulating Instrument Adapter
00815440021856Senhance® Needle Driver, Articulating (US)
00815440021825Senhance® Bipolar Atraumatic Grasper, Articulating (US)
00815440021924Olympus ENDOEYE 3D 10 mm Endoscope Adapter

Trademark Results [Senhance]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SENHANCE
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.