CANNULA

GUDID 14953170043168

OLYMPUS MEDICAL SYSTEMS CORP.

Cholangiopancreatography catheter, reusable Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter Tracheobronchial contrast medium catheter

• Primary Device ID: 14953170043168
• NIH Device Record Key: cc0c4963-a2ea-4f7f-b176-6d0bec0fcf28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CANNULA
• Version Model Number: PR-2B-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
• 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	04953170043161 [Primary]
GS1	14953170043168 [Package]; Contains: 04953170043161; Package: [1 Units]; In Commercial Distribution
GS1	84953170043167 [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

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

Moist Heat or Steam Sterilization

[14953170043168]

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