AccessGUDID - DEVICE: SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACK (00723896026854)

GUDID

Device Identifier (DI) Information

Brand Name: SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACK
Version or Model: 71098133 UNS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71098133 UNS
Company Name: PRACTICON, INC.

Primary DI Number: 00723896026854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Silicone tube used to help seat a clear aligner by biting down on the device. 24 per pack

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?
63676	Orthodontic aligner/retainer seater, single-use	A small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECQ	Aligner, Bracket, Orthodontic

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: 89f707b2-bfce-480e-93c4-49cc7fd1916b
Public Version Date: August 15, 2024
Public Version Number: 1
DI Record Publish Date: August 07, 2024