Nephroscopy guide

GUDID 04059082009650

SOPRO-COMEG GmbH

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Primary Device ID	04059082009650
NIH Device Record Key	a35d7a8b-f04a-46dd-9de7-ef682809183d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nephroscopy guide
Version Model Number	195 800 040BC
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	false
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	04059082009650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K945262

FDA Product Code

FAJ	Cystoscope and accessories, flexible/rigid