Sagittal Appliance

GUDID 00889989038682

Orthodontic palate expander/teeth aligner, self-removable

Primary Device ID	00889989038682
NIH Device Record Key	fc0b626b-082a-416d-96fb-87ccd4c2adb9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sagittal Appliance
Version Model Number	3000-0044
Company DUNS	158312728
Company Name	ALLESEE AOA-PRO
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	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
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	00889989038682 [Primary]

KMY	POSITIONER, TOOTH, PREFORMED

Steralize Prior To Use	false
Device Is Sterile	false

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