OrthoFX Home Impression Kit

GUDID 00860003321744

Dental impression material kit, single-use

Primary Device ID	00860003321744
NIH Device Record Key	79f3d880-326a-4740-8ce9-c65a17f25444
Commercial Distribution Status	In Commercial Distribution
Brand Name	OrthoFX Home Impression Kit
Version Model Number	HIK1-rev
Company DUNS	033755180
Company Name	ORTHOFX
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	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	00860003321744 [Primary]

ELW	Material, Impression

Steralize Prior To Use	false
Device Is Sterile	false

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