CONMED CleanGuide

Basic Information

• Brand Name: CONMED CleanGuide
• Primary DI: 06971890564665
• Version / Model: CG-18-1
• Company Name: Jiangsu Grit Medical Technology Co., Ltd.
• Labeler DUNS: 554536935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-16
• Public Version: 2
• Public Version Date: 2021-08-30
• Public Version Status: Update
• Public Device Record Key: 049cb5ab-989a-46cd-90e4-52fd8963c435

Device Description

Disposable OTW Esophageal Dilators

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KNQ	Dilator, Esophageal	Gastroenterology, Urology	876.5365	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38821	Endoscopic-access dilator, single-use	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971890564665	GS1
Package	16971890564662	GS1	Inner Box	3	In Commercial Distribution
Package	26971890564669	GS1	Outer Box	27	In Commercial Distribution