PRO3DURE THERMEO Blank

GUDID EPRCD1010127

Custom-made mouthguard

Primary Device ID	EPRCD1010127
NIH Device Record Key	6d9d02df-0011-4b98-a8ff-c7a562a6f729
Commercial Distribution Status	In Commercial Distribution
Brand Name	PRO3DURE THERMEO Blank
Version Model Number	color A3, height 20 mm
Company DUNS	312947842
Company Name	pro3dure medical GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
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
HIBCC	EPRCD1010127 [Primary]

MQC	Mouthguard, Prescription

Steralize Prior To Use	false
Device Is Sterile	false

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EPRCD1010127	THERMEO Blank, diameter 98.5 mm, height 20 mm
EPRCD1010126	THERMEO Blank, diameter 98.5 mm, height 20 mm
EPRCD1010125	THERMEO Blank, diameter 98.5 mm, height 20 mm
EPRCD1022006	THERMEO Blank, diameter 98.5 mm, height 25 mm