AccessGUDID - DEVICE: by Humankind (00850007634483)

GUDID

Device Identifier (DI) Information

Brand Name: by Humankind
Version or Model: BHK-DV1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: By Humankind, Inc.

Primary DI Number: 00850007634483
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117642980 *Terms of Use

Device Description: By Humankind, BHK-DV1 Product Profile: The refillable, durable glass container is protected with a silicone top. The side notch design makes it easy to refill and re-thread your floss. The floss is spun around a sugarcane-based bioplastic spool and shipped in a compostable pouch to eliminate single-use plastic from your oral care routine. Each refill spool has 30 yards of biodegradable silk floss. Refills are shipped in a compostable pouch made from kraft paper with a sugar-based lining (pbat). Each refill eliminates 0.89oz of single-use plastic waste.

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?
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: ba1ad7fe-71d5-4934-be2b-9f835c20d800
Public Version Date: July 10, 2023
Public Version Number: 1
DI Record Publish Date: July 01, 2023