Go-CHx Gel - 0.8% Chlorhexidine

Primary DI
D8374810000
Brand
Go-CHx Gel - 0.8% Chlorhexidine
Company
Taub Products
Model
Kit - 3 mL Syr - 2 pk
Catalog number
48-1000
Device description
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.
Published
2016-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMEExternal Cleaning Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMEExternal Cleaning SolutionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152322000Resolve 2.0Denali Corporation2015-12-16PME

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8374810000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cavity varnishA liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat. Store at room temperature. See SDS.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.201.798.5353customerservice@taubdental.com

Regulatory Flags#

DUNS number
067488114
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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