AccessGUDID - DEVICE: e-1 Purple 37% Phosphoric acid gel etchant (D8918012024)

GUDID

Device Identifier (DI) Information

Brand Name: e-1 Purple 37% Phosphoric acid gel etchant
Version or Model: 8012024
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8012024
Company Name: E DENTAL PRODUCTS

Primary DI Number: D8918012024
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 081045871 *Terms of Use

Device Description: 24 pack of 1.2 ml Purple 37% phosphoric acid etchant gel

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?
36153	Dental etching solution	An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	Agent, Tooth Bonding, Resin

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
Storage Environment Temperature: between 50 and 75 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.2 Milliliter

Device Record Status

Public Device Record Key: ca72cb69-4a33-454f-b7e2-1b77b7e2a6cf
Public Version Date: February 10, 2020
Public Version Number: 1
DI Record Publish Date: January 31, 2020