ELIMINATOR

Basic Information

• Brand Name: ELIMINATOR
• Primary DI: 20653405050916
• Version / Model: 000348
• Catalog Number: 000348
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-02
• Public Version: 1
• Public Version Date: 2018-08-02
• Public Version Status: New
• Public Device Record Key: c0a6a2ef-c51a-497c-92b3-f445be1fa901

Device Description

6MM X 2CM PET BILIARY BALLOON DILATOR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	Stents, drains and dilators for the biliary ducts	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35808	Stone/foreign-body extraction set	A collection of surgical instruments intended to remove calculi, debris, and/or to retrieve fragments of catheter tubing, wire guides, pull wires, plastic stents and other foreign bodies during urological and/or gastroenterological interventions. It typically consists of a retrieval basket and/or grasping forceps, an introducing sheath or sleeve, and possibly a guidewire; the exact design of the set will vary depending on the surgical method. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20653405050916	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K920361	000

Device Sizes

Type	Value	Unit	Text
Pressure	150	Pound per Square Inch
Device Size Text, specify			10.3 BAR
Device Size Text, specify			10.2 ATM
Outer Diameter	6	Millimeter
Length	2	Centimeter