AccessGUDID - DEVICE: e-1 Crimson 37% Phosphoric acid etchant gel (D8915601601)

GUDID

Device Identifier (DI) Information

Brand Name: e-1 Crimson 37% Phosphoric acid etchant gel
Version or Model: 5601601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5601601
Company Name: E DENTAL PRODUCTS

Primary DI Number: D8915601601
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 081045871 *Terms of Use

Device Description: 2 pack of 30ml Crimson 37% Phosphoric acid etchant gel. Includes 5 empty 1.2ml or 3ml syringes and connector.

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: 30 Milliliter

Device Record Status

Public Device Record Key: ca4dc740-4c26-4874-89c3-7854e1c4634f
Public Version Date: April 09, 2018
Public Version Number: 1
DI Record Publish Date: March 09, 2018