AccessGUDID - DEVICE: SmileGoods PikPak Interproximal Cleaners (00723896010983)

GUDID

Device Identifier (DI) Information

Brand Name: SmileGoods PikPak Interproximal Cleaners
Version or Model: SP618
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-09878
Company Name: PRACTICON, INC.

Primary DI Number: 00723896010983
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 72
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Put the power of a healthier smile in your patients’ pockets SmileGoods PikPak Interproximal Cleaners offer the same high quality at one-third the price of leading brands. The soft elastic bristles and flexible tapered handle are safe and effective for use on orthodontics, implants, and bridges. Business card-sized package slips easily into pocket, wallet, or purse, so patients can clean where their toothbrushes can’t go—on the go.

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?
33208	Periodontal pick/brush, reusable	A manual, pointed, oral hygiene device with a soft tip or bristles intended to be used to stimulate and massage the gums to promote good periodontal (gum) condition, and to clean and remove plaque and debris from between the teeth and gingival surfaces. It may also be referred to as an interdental/interproximal brush and is intended for use in the home. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JET	Pick, Massaging

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: 8cf0c1a2-4b39-41d6-8156-ac5715bce72f
Public Version Date: January 08, 2021
Public Version Number: 2
DI Record Publish Date: July 19, 2018