N/A 000230

GUDID 10653405053699

CONMED Endoscopic Overtube

Conmed Corporation

Rigid endoscope obturator

• Primary Device ID: 10653405053699
• NIH Device Record Key: 4fff5853-34bd-4d9d-aad6-5846bd381662
• Commercial Distribution Discontinuation: 2022-06-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: N/A
• Version Model Number: 000230
• Catalog Number: 000230
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	10653405053699 [Primary]
GS1	30653405053693 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942044

FDA Product Code

• FED: endoscopic access overtube, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-24

On-Brand Devices [N/A]

• 20653405050855: Marked Spring Tip Guidewire
• 10653405053699: CONMED Endoscopic Overtube