Go-CHx Gel - 0.8% Chlorhexidine 48-5000

GUDID D8374850000

Go-CHx Gel is a syringeable thin, non-alcohol based gel containing 0.8% Chlorhexidine in a water soluble formula. Because of its water solubility, and low viscosity, when applied to dental restorations, it acts as a cleansing agent and does not affect bond strengths. This gel is provided in easy to use syringes with flock tips to precisely deliver the gel to the intended areas. External cleaning solution. Go-CHx Gel is recommended for use on dental restorations, prior to insertion. After applying Go-CHx Gel to cleanse the restoration, the surface of the restoration should be rinsed thoroughly with water, and then air dried prior to insertion.

Taub Products

Dental cavity varnish Dental cavity varnish

• Primary Device ID: D8374850000
• NIH Device Record Key: 8b6b0270-6e87-43f4-b96f-869ac9989c23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Go-CHx Gel - 0.8% Chlorhexidine
• Version Model Number: 0.6 mL Syr - 1ea - Evaluator
• Catalog Number: 48-5000
• Company DUNS: 067488114
• Company Name: Taub Products
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1.201.798.5353
• Email: customerservice@taubdental.com
• Phone: +1.201.798.5353
• Email: customerservice@taubdental.com

Device Dimensions

• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat. Store at room temperature. See SDS.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat. Store at room temperature. See SDS.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8374850000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152322

FDA Product Code

• PME: External Cleaning Solution

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-05

On-Brand Devices [Go-CHx Gel - 0.8% Chlorhexidine]

• D8374850000: Go-CHx Gel is a syringeable thin, non-alcohol based gel containing 0.8% Chlorhexidine in a water
• D8374810050: Go-CHx Gel is a syringeable thin, non-alcohol based gel containing 0.8% Chlorhexidine in a water
• D8374810000: Go-CHx Gel is a syringeable thin, non-alcohol based gel containing 0.8% Chlorhexidine in a water