AccessGUDID - DEVICE: OrthoFX (00860003321765)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoFX
Version or Model: TB Aligner
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ORTHOFX

Primary DI Number: 00860003321765
Issuing Agency: GS1
Commercial Distribution End Date: November 27, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 033755180 *Terms of Use

Device Description: Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
35310	Orthodontic retainer	An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYT	Maintainer, Space Preformed, 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: 46b474d6-c23c-43d5-97c4-cf94ee23fb2d
Public Version Date: August 05, 2021
Public Version Number: 7
DI Record Publish Date: March 18, 2020