AccessGUDID - DEVICE: FlossBow Ortho Flossers (00723896010860)

GUDID

Device Identifier (DI) Information

Brand Name: FlossBow Ortho Flossers
Version or Model: 7109860
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-09860
Company Name: PRACTICON, INC.

Primary DI Number: 00723896010860
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: ur exclusive FlossBow Orthodontic Flosser is specially designed to help patients quickly and easily floss behind braces—without a threader. Floss faster and more often. Floss anywhere—on the go! Floss with one hand. With other orthodontic flossers, floss can pop loose from the thin extension. FlossBow features strong floss and secure end points to solve this problem. Plus, its double-ended design is like having two flossers in one! Ideal for both ortho and non-ortho users.

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?
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: 06733907-02af-4777-84c7-504819a4516b
Public Version Date: August 20, 2018
Public Version Number: 1
DI Record Publish Date: July 19, 2018