Senhance

GUDID 00815440021825

Senhance® Bipolar Atraumatic Grasper, Articulating (US)

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	00815440021825
NIH Device Record Key	6a1ee8e7-8e30-4ddb-935d-c906fb0616de
Commercial Distribution Status	In Commercial Distribution
Brand Name	Senhance
Version Model Number	X9007672
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	00815440021825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K211325

FDA Product Code

NAY	System, Surgical, Computer Controlled Instrument