CONMED CleanGuide

GUDID 06971890564535

Disposable OTW Esophageal Dilators

Jiangsu Grit Medical Technology Co., Ltd.

Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use

• Primary Device ID: 06971890564535
• NIH Device Record Key: ca5658ae-2911-435c-ac25-96f50f13a882
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONMED CleanGuide
• Version Model Number: CG-05-1
• Company DUNS: 554536935
• Company Name: Jiangsu Grit Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971890564535 [Primary]
GS1	16971890564532 [Package]; Package: Inner Box [3 Units]; In Commercial Distribution
GS1	26971890564539 [Package]; Package: Outer Box [54 Units]; In Commercial Distribution

FDA Product Code

• KNQ: Dilator, Esophageal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-08-27
• Device Publish Date: 2021-04-11

On-Brand Devices [CONMED CleanGuide]

• 06971890564559: Disposable OTW Esophageal Dilators
• 06971890564542: Disposable OTW Esophageal Dilators
• 06971890564535: Disposable OTW Esophageal Dilators