CANNULA

GUDID 14953170154574

OLYMPUS MEDICAL SYSTEMS CORP.

Cholangiopancreatography catheter, reusable ERCP catheter, non-balloon, non-electrical, reusable ERCP catheter, non-balloon, non-electrical, reusable ERCP catheter, non-balloon, non-electrical, reusable ERCP catheter, non-balloon, non-electrical, reusable ERCP catheter, non-balloon, non-electrical, reusable ERCP catheter, non-balloon, non-electrical, reusable ERCP catheter, non-balloon, non-electrical, reusable ERCP catheter, non-balloon, non-electrical, reusable ERCP catheter, non-balloon, non-electrical, reusable

Primary Device ID	14953170154574
NIH Device Record Key	ec44ef9f-2090-40ef-a15a-6727aac41cc3
Commercial Distribution Status	In Commercial Distribution
Brand Name	CANNULA
Version Model Number	PR-304Q
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	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170154577 [Primary]
GS1	14953170154574 [Package] Contains: 04953170154577 Package: [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K950729

FDA Product Code

ODD	Endoscopic retrograde cholangiopancreatography (ERCP) cannula