AccessGUDID - DEVICE: Waxed Dental Floss (10810063755642)

GUDID

Device Identifier (DI) Information

Brand Name: Waxed Dental Floss
Version or Model: 8250031
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0-PR
Company Name: SAFCO DENTAL SUPPLY CO.

Primary DI Number: 10810063755642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 144
Labeler D-U-N-S® Number*: 020417380 *Terms of Use

Device Description: Waxed Dental Floss, unflavored, 12 yds - sample size, shred resistant nylon, purple flip top container, 144/box

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):	Yes
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: ec62ef46-95cb-40e6-8d07-5b06c697fcc5
Public Version Date: August 22, 2023
Public Version Number: 1
DI Record Publish Date: August 14, 2023