AccessGUDID - DEVICE: EDTA (00818365020058)

GUDID

Device Identifier (DI) Information

Brand Name: EDTA
Version or Model: EEEDTA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EDGE ENDO LLC

Primary DI Number: 00818365020058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078474365 *Terms of Use

Device Description: EdgeEndo EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endotontic procedures to remove the smear layer.

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?
34524	Dental tooth-cleaning solution	A liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which may be included. 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
Total Volume: 480 Milliliter

Device Record Status

Public Device Record Key: 68647e55-5fe3-4058-8783-2060d46b957c
Public Version Date: October 05, 2018
Public Version Number: 3
DI Record Publish Date: September 28, 2017