Rickonator

GUDID D82853004020

Removable dental occlusal splint, custom-made

Primary Device ID	D82853004020
NIH Device Record Key	2fa6be43-8410-47db-8b60-61151f0ffed0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Rickonator
Version Model Number	5300402
Company DUNS	113352686
Company Name	FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
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	false
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
HIBCC	D82853004020 [Primary]

DZC	Wire, Orthodontic

Steralize Prior To Use	false
Device Is Sterile	false