SINGLE USE CANNULA

GUDID 14953170154703

OLYMPUS MEDICAL SYSTEMS CORP.

Cholangiopancreatography catheter, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use ERCP catheter, non-balloon, non-electrical, single-use

• Primary Device ID: 14953170154703
• NIH Device Record Key: 289a67b9-98f0-4133-b7a5-afb4d6c171fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINGLE USE CANNULA
• Version Model Number: PR-416Q
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	04953170154706 [Primary]
GS1	14953170154703 [Package]; Contains: 04953170154706; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950729

FDA Product Code

• ODD: Endoscopic retrograde cholangiopancreatography (ERCP) cannula

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [SINGLE USE CANNULA]

• 14953170154734: SINGLE USE CANNULA
• 14953170154727: SINGLE USE CANNULA
• 14953170154710: PR-418Q
• 14953170154703: PR-416Q
• 14953170154697: PR-414Q