AccessGUDID - DEVICE: Jade (00353045000659)

GUDID

Device Identifier (DI) Information

Brand Name: Jade
Version or Model: 20-00004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-00004
Company Name: DHARMA RESEARCH, INC.

Primary DI Number: 00353045000659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 078444642 *Terms of Use

Device Description: Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 25 x 1.2ml Syringes, 50 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 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 [?]
K150696	000

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: 1.2 Milliliter

Device Record Status

Public Device Record Key: 9099f5cb-8a96-430b-b2c9-fb29374708cd
Public Version Date: March 11, 2019
Public Version Number: 3
DI Record Publish Date: October 07, 2016