AccessGUDID - DEVICE: Jade (00353045000680)

GUDID

Device Identifier (DI) Information

Brand Name: Jade
Version or Model: 20-00007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-00007
Company Name: DHARMA RESEARCH, INC.

Primary DI Number: 00353045000680
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078444642 *Terms of Use

Device Description: Jade Green 37% Phosphoric Acid Etchant Gel - 1 x 10ml Syringe, 20 Pre-bent 23ga Tips & Instruction Insert

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

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 10 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: 0d882b0d-d1fc-4d63-a1ce-dcb433cf11d4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 07, 2016