DURAGLIDE 007143

GUDID 00653405053739

DURAGLIDE STONE BALLOON 8.5MM, BELOW

Conmed Corporation

Biliary stone retrieval balloon catheter

• Primary Device ID: 00653405053739
• NIH Device Record Key: 20cca5a1-7a0a-4278-b8b5-6c7b07b2c4a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAGLIDE
• Version Model Number: 007143
• Catalog Number: 007143
• 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: 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(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Dimensions

• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405053739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993892

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

Sterilization

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

[00653405053739]

Ethylene Oxide

[00653405053739]

Ethylene Oxide

[00653405053739]

Ethylene Oxide

[00653405053739]

Ethylene Oxide

[00653405053739]

Ethylene Oxide

[00653405053739]

Ethylene Oxide

[00653405053739]

Ethylene Oxide

[00653405053739]

Ethylene Oxide

[00653405053739]

Ethylene Oxide

[00653405053739]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

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