Flex-X / IMAGE 1 S

GUDID 04048551344385

Video Uretero-Renoscope FLEX-XC

Karl Storz GmbH & Co. KG

Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable Flexible video ureterorenoscope, reusable

Primary Device ID	04048551344385
NIH Device Record Key	84e0cd01-b781-49fa-a0d9-fff3deea6460
Commercial Distribution Status	In Commercial Distribution
Brand Name	Flex-X / IMAGE 1 S
Version Model Number	11278VSU
Company DUNS	315731430
Company Name	Karl Storz GmbH & Co. KG
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	false
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	04048551344385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141250

FDA Product Code

FGB	Ureteroscope and accessories, flexible/rigid