Senhance Ultrasonic 300-21011

GUDID 00815440021122

Adapter, Senhance Ultrasonic

TRANSENTERIX, INC.

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Primary Device ID	00815440021122
NIH Device Record Key	4c77bf3d-f3b0-407c-a62a-b297739cb959
Commercial Distribution Status	In Commercial Distribution
Brand Name	Senhance Ultrasonic
Version Model Number	X9007618
Catalog Number	300-21011
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	00815440021122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182421

FDA Product Code

NAY	System, Surgical, Computer Controlled Instrument