CONMED

Basic Information

• Brand Name: CONMED
• Primary DI: 20653405986673
• Version / Model: 000287
• Catalog Number: 000287
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-15
• Public Version: 2
• Public Version Date: 2023-10-05
• Public Version Status: Update
• Public Device Record Key: 289df491-9a5e-4db6-bdeb-95dcc861e172
• Distribution End Date: 2023-10-04

Device Description

American Dilator, 57 F

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNQ	Dilator, esophageal	Gastroenterology, Urology	876.5365	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35009	Over-guidewire oesophageal dilator	A surgical instrument in the form of a slender, hollow cylinder made of metal, plastic or other suitable material, designed to dilate oesophageal strictures/passages after being passed over a pre-positioned guidewire, typically in sequentially increasing sizes. It is commonly used prior to and to assist in a gastroscopy and is available in a variety of sizes and flexibilities. Commonly known as a Savary-Guillard dilator it will typically be used during fluoroscopy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	10653405986676	GS1
Primary	20653405986673	GS1

Customer Contacts

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