AccessGUDID - DEVICE: CHX (10818207020304)

GUDID

Device Identifier (DI) Information

Brand Name: CHX
Version or Model: 502450
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vista Dental

Primary DI Number: 10818207020304
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 036623932 *Terms of Use

Device Description: 2% Chlorhexidine Gluconate - use prior to restorative preparations of crowns and composites. Restorative kit includes (4) 1.2ml prefilled syringes & 40 Sol-u-Flo tips.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
45500	Root canal cleaning solution	A fluid or gel material intended to be used in dentistry to facilitate cleaning/irrigation of the root canal during/after endodontic instrumentation to remove the smear layer, pulpal tissue, necrotic materials, and bacteria from the root canal, before placement of the endodontic filling; it may also act as a lubricant to facilitate the passage of an instrument (e.g., file/rasp) into the root canal. It is typically available as a disinfecting solution (e.g., chlorhexidine, sodium hypochlorite solution) delivered into the canal with an irrigation needle, or similar device, providing mechanical and possibly chemical cleaning of the canal. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KJJ	Cleanser, Root Canal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 950a46e6-c59f-43f3-81b3-6c9f3d7ebe05
Public Version Date: September 13, 2021
Public Version Number: 4
DI Record Publish Date: July 31, 2018