AccessGUDID - DEVICE: Quala (D023Q0550261)

GUDID

Device Identifier (DI) Information

Brand Name: Quala
Version or Model: Q055026
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Q055026
Company Name: NATIONAL DISTRIBUTION & CONTRACTING, INC.

Primary DI Number: D023Q0550261
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009831413 *Terms of Use

Device Description: Quala Alloy Amalgam 2 Spill FS 50/JR

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:	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?
16367	Dental amalgam	A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). The amalgam may be in either powder or tablet form, or in capsules, with portions of alloy and mercury predosed by the manufacturer. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJJ	Alloy, Amalgam

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K820617	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: 61f6cd76-0543-4e8c-bcc3-d440fe80fb49
Public Version Date: September 19, 2022
Public Version Number: 3
DI Record Publish Date: February 13, 2017