AccessGUDID - DEVICE: Ultimate Flosser (Blue fork with White Body) (D248222210)

GUDID

Device Identifier (DI) Information

Brand Name: Ultimate Flosser (Blue fork with White Body)
Version or Model: 22221
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAGER WORLDWIDE, INC.

Primary DI Number: D248222210
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009277971 *Terms of Use

Device Description: Floss Holder/dispenser

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?
64844	Dental floss dispenser	A manual device, similar to a bench tape dispenser, intended to be used to hold and facilitate the cutting of dental floss sections by an operator, typically with minimal contact to prevent cross-contamination; it is intended for use in a clinical setting or in the home. This is a reusable device.	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: e89867f2-5470-485a-90f2-81e1a41ee22c
Public Version Date: April 07, 2023
Public Version Number: 1
DI Record Publish Date: March 30, 2023