AccessGUDID - DEVICE: Quala (D023Q4000418)

GUDID

Device Identifier (DI) Information

Brand Name: Quala
Version or Model: Q40004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Q40004
Company Name: NATIONAL DISTRIBUTION & CONTRACTING, INC.

Primary DI Number: D023Q4000418
Issuing Agency: HIBCC
Commercial Distribution End Date: April 25, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 009831413 *Terms of Use

Device Description: Quala Etch 1.2 ML Gel Syringe 4 Syringes 20 Tips

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):	Yes
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 [?]
K941899	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
No Device Sizes

Device Record Status

Public Device Record Key: ab808c88-2e17-4f47-b7b2-10a7929a63bb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 13, 2017