DURAGLIDE 007143

GUDID 20653405053733

STONE BLN 3L,8.5MM,BELOW

Conmed Corporation

Biliary stone retrieval balloon catheter Biliary stone retrieval balloon catheter Biliary stone retrieval balloon catheter Biliary stone retrieval balloon catheter Biliary stone retrieval balloon catheter Biliary stone retrieval balloon catheter Biliary stone retrieval balloon catheter Biliary stone retrieval balloon catheter Biliary stone retrieval balloon catheter

• Primary Device ID: 20653405053733
• NIH Device Record Key: e5d79b7f-fc94-4013-855b-c5c790d41882
• 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(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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405053739 [Previous]
GS1	20653405053733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993892

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

Sterilization

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

[20653405053733]

Ethylene Oxide

[20653405053733]

Ethylene Oxide

[20653405053733]

Ethylene Oxide

[20653405053733]

Ethylene Oxide

[20653405053733]

Ethylene Oxide

[20653405053733]

Ethylene Oxide

[20653405053733]

Ethylene Oxide

[20653405053733]

Ethylene Oxide

[20653405053733]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-26
• Device Publish Date: 2020-10-16

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