AccessGUDID - DEVICE: QUALA (D023Q480331)

GUDID

Device Identifier (DI) Information

Brand Name: QUALA
Version or Model: Q48033
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Q48033
Company Name: NATIONAL DISTRIBUTION & CONTRACTING, INC.

Primary DI Number: D023Q480331
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009831413 *Terms of Use

Device Description: QUALA PTFE PLAIN DENTAL FLOSS 10 METER 72/CS

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):	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?
11158	Dental floss	A string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JES	Floss, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: aaddf2d7-d6c4-4035-b17e-71121a4227b9
Public Version Date: October 24, 2018
Public Version Number: 1
DI Record Publish Date: September 23, 2018