CANNULA

GUDID 14953170043601

OLYMPUS MEDICAL SYSTEMS CORP.

Cholangiopancreatography catheter, reusable

• Primary Device ID: 14953170043601
• NIH Device Record Key: 55f73a7e-b8fa-4fe5-ad6c-cec72c12002c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CANNULA
• Version Model Number: PR-104Q-1
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 2
• 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	04953170043604 [Primary]
GS1	14953170043601 [Package]; Contains: 04953170043604; Package: [1 Units]; In Commercial Distribution
GS1	84953170043600 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950729

FDA Product Code

• ODD: Endoscopic retrograde cholangiopancreatography (ERCP) cannula

Sterilization

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

[14953170043601]

Moist Heat or Steam Sterilization

[14953170043601]

Moist Heat or Steam Sterilization

[14953170043601]

Moist Heat or Steam Sterilization

[14953170043601]

Moist Heat or Steam Sterilization

[14953170043601]

Moist Heat or Steam Sterilization

[14953170043601]

Moist Heat or Steam Sterilization

[14953170043601]

Moist Heat or Steam Sterilization

[14953170043601]

Moist Heat or Steam Sterilization

[14953170043601]

Moist Heat or Steam Sterilization

[14953170043601]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [CANNULA]

• 14953170154680: PR-326Q
• 14953170154659: PR-313Q
• 14953170154635: PR-310Q
• 14953170154604: PR-309Q
• 14953170154574: PR-304Q
• 14953170043885: PR-126Q-1
• 14953170043847: PR-113Q-1
• 14953170043762: PR-110Q-1
• 14953170043724: PR-109Q-1
• 14953170043601: PR-104Q-1
• 14953170043571: PR-24Q-1
• 14953170043168: PR-2B-1