Endoscope 5.5 MM Sterile, Reusable

GUDID 00699753018952

Terumo Cardiovascular Systems Corporation

Rigid reconstructive surgery endoscope Rigid reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope Rigid optical reconstructive surgery endoscope

Primary Device ID	00699753018952
NIH Device Record Key	0efda458-f075-4617-aa38-6b7fbc2d636e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Endoscope 5.5 MM Sterile, Reusable
Version Model Number	MCENDO550
Company DUNS	177655466
Company Name	Terumo Cardiovascular Systems Corporation
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	00699753018952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160206

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories