OrthoFX

GUDID 00860003321737

Orthodontic retainer

Primary Device ID	00860003321737
NIH Device Record Key	de636d3b-0f9c-4374-8c97-fb0086fc221e
Commercial Distribution Status	In Commercial Distribution
Brand Name	OrthoFX
Version Model Number	TBR1-rev
Company DUNS	033755180
Company Name	ORTHOFX
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860003321737 [Primary]

DYT	Maintainer, Space Preformed, Orthodontic

Steralize Prior To Use	false
Device Is Sterile	false

18600033217131	ZR1
18600033217377	TBR1
18600033217063	Z1
18600033217445	HIK1
00860003321706	Updated UDI submission for Zendura material aligners.
00860003321737	OrthoFX Retainer
00860003321713	OrthoFX Retainer
00086000332174	Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition.
00860003321765	Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition.
00860003321775	Boil and Bite Home Impression Kit.

Mark Image Registration \| Serial	Company Trademark Application Date
ORTHOFX 88036457 5846789 Live/Registered	Smylio Inc. 2018-07-13