AccessGUDID - DEVICE: Go-CHx Gel - 0.8% Chlorhexidine (D8374810050)

GUDID

Device Identifier (DI) Information

Brand Name: Go-CHx Gel - 0.8% Chlorhexidine
Version or Model: 3 mL Syr - 1ea.
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 48-1005
Company Name: Taub Products

Primary DI Number: D8374810050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067488114 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35698	Dental cavity varnish	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PME	External Cleaning Solution

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152322	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from heat. Store at room temperature. See SDS.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: 0453fdce-7fdf-47b2-88ff-c0380873c9bb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 05, 2016