SmileSet Night Guard

GUDID 00860014476136

Mouthguard, reusable

Primary Device ID	00860014476136
NIH Device Record Key	4d9cf224-d06e-425b-8f2a-85addce9faf2
Commercial Distribution Status	In Commercial Distribution
Brand Name	SmileSet Night Guard
Version Model Number	160-0101
Company DUNS	119338749
Company Name	Ortho Dental Lab LLC
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	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00860014476136 [Primary]

DYT	Maintainer, Space Preformed, Orthodontic

Steralize Prior To Use	false
Device Is Sterile	false

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