CONMED CLEARGUARD 000522

GUDID 20653405063237

CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR OLYMPUS AND FUJINON GI ENDOSCOPES

Conmed Corporation

Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use

• Primary Device ID: 20653405063237
• NIH Device Record Key: bb474cf9-1a3f-4465-a407-30f8b7ac577b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONMED CLEARGUARD
• Version Model Number: 000522
• Catalog Number: 000522
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 100
• 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: 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
• 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
• 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	00653405063233 [Unit of Use]
GS1	10653405063230 [Primary]
GS1	20653405063237 [Package]; Contains: 10653405063230; Package: CASE [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090851

FDA Product Code

• ODC: Endoscope channel accessory

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-10-12
• Device Publish Date: 2017-09-15

On-Brand Devices [CONMED CLEARGUARD]

• 10653405063254: CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR PENTAX GI ENDOSCOPES
• 10653405063247: CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR OLYMPUS AND FUJINON GI ENDOSCOPES
• 20653405063268: CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR PENTAX GI ENDOSCOPES
• 20653405063237: CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR OLYMPUS AND FUJINON GI ENDOSCOPES