AccessGUDID - DEVICE: Chlor-XTRA (10818207020502)

GUDID

Device Identifier (DI) Information

Brand Name: Chlor-XTRA
Version or Model: 503850
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vista Dental

Primary DI Number: 10818207020502
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 036623932 *Terms of Use

Device Description: Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation, debridement and cleansing of root canals during and after instrumentation. 12ml pre-filled syringes.

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:	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?
59523	Antimicrobial wound irrigation solution	A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. 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: bc63ed82-fbc0-430d-a382-d085ac9d79d7
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: August 06, 2018