URETERO-RENO FIBERSCOPE N5781844

GUDID 04953170435096

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope Flexible fibreoptic ureterorenoscope

Primary Device ID	04953170435096
NIH Device Record Key	4e3d0d04-311f-4b64-8e67-5123ca0d8ff5
Commercial Distribution Status	In Commercial Distribution
Brand Name	URETERO-RENO FIBERSCOPE
Version Model Number	OLYMPUS URF-P7
Catalog Number	N5781844
Company DUNS	711789789
Company Name	OLYMPUS MEDICAL SYSTEMS CORP.
Device Count	1
DM Exempt	true
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	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx
Phone	+1(800)401-1086
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170435096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181451

FDA Product Code

FGB	Ureteroscope And Accessories, Flexible/Rigid