Nephroscope

GUDID 04059082030050

SOPRO-COMEG GmbH

Rigid nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope Rigid optical nephroscope

Primary Device ID	04059082030050
NIH Device Record Key	1fbac5c1-916c-4b75-a6ec-a99b68f647dd
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nephroscope
Version Model Number	165 800 000
Company DUNS	507185952
Company Name	SOPRO-COMEG GmbH
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	true
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	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059082030050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K945262

FDA Product Code

FAJ	Cystoscope and accessories, flexible/rigid