DURAGLIDE

Basic Information

• Brand Name: DURAGLIDE
• Primary DI: 20653405053764
• Version / Model: 000637
• Catalog Number: 000637
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2022-06-07
• Public Version Status: Update
• Public Device Record Key: 4d4f0882-0ec2-4bda-bc24-ffe31819f71c
• Distribution End Date: 2022-06-06

Device Description

DURAGLIDE Stone Balloon, 11.5mm, 7f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCA	CATHETER, BILIARY, SURGICAL	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46715	ERCP catheter, balloon, non-electrical, stone-retrieval	A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20653405053764	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K920342	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			.89 Millimeter Wire Outer Diameter
Device Size Text, specify			11.5 Millimeter Balloon Outer Diameter
Device Size Text, specify			2.3 Millimeter Catheter Outer Diameter
Device Size Text, specify			7 French Catheter Outer Diameter
Device Size Text, specify			0.035 Inch Wire Outer Diameter
Device Size Text, specify			1.5 Milliliter Balloon Maximum Inflation Volume
Device Size Text, specify			200 Centimeter Catheter Length