DURAGLIDE 000647

GUDID 20653405053801

DURAGLIDE Stone Balloon, 15.0mm, 7-5f

Conmed Corporation

Biliary stone retrieval balloon catheter Biliary stone retrieval balloon catheter ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval

• Primary Device ID: 20653405053801
• NIH Device Record Key: 0e28fd5b-6776-4449-9f1d-86c6ecf7761d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAGLIDE
• Version Model Number: 000647
• Catalog Number: 000647
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	20653405053801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920342

FDA Product Code

• GCA: CATHETER, BILIARY, SURGICAL

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: 2016-09-24

On-Brand Devices [DURAGLIDE]

• 00653405053753: DURAGLIDE STONE BALLOON 15MM, BELOW
• 00653405053746: DURAGLIDE STONE BALLOON 11.5MM, BELOW
• 00653405053739: DURAGLIDE STONE BALLOON 8.5MM, BELOW
• 00653405053722: DURAGLIDE STONE BALLOON 15MM, ABOVE
• 00653405053715: DURAGLIDE STONE BALLOON 11.5MM, ABOVE
• 00653405053708: DURAGLIDE STONE BALLOON 8.5MM, ABOVE
• 20653405053801: DURAGLIDE Stone Balloon, 15.0mm, 7-5f
• 20653405053795: DURAGLIDE Stone Balloon, 11.5mm, 7-5f
• 20653405053788: DURAGLIDE Stone Balloon, 8.5mm, 7-5f
• 20653405053771: DURAGLIDE Stone Balloon, 15.0mm, 7f
• 20653405053764: DURAGLIDE Stone Balloon, 11.5mm, 7f
• 20653405053757: STONE BLN 3L,15MM BELOW
• 20653405053733: STONE BLN 3L,8.5MM,BELOW