AccessGUDID - DEVICE: Infant Toothbrush (10810063755789)

GUDID

Device Identifier (DI) Information

Brand Name: Infant Toothbrush
Version or Model: 8250085
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 201
Company Name: SAFCO DENTAL SUPPLY CO.

Primary DI Number: 10810063755789
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 020417380 *Terms of Use

Device Description: Infant Toothbrush, tapered head, child/pedo soft, easy to hold scissor shaped grip, 2 assorted colors, 24/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:	No
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?
31817	Basic manual toothbrush	An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFW	Toothbrush, Manual

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: 23a56490-82b0-40da-8c79-26a26695638e
Public Version Date: August 15, 2023
Public Version Number: 1
DI Record Publish Date: August 07, 2023