Elements by Hedy HE-PFS

GUDID D903HEPFS1

Dental impression material kit, single-use

Primary Device ID	D903HEPFS1
NIH Device Record Key	47e52467-846c-4c36-834e-f2098b516712
Commercial Distribution Status	In Commercial Distribution
Brand Name	Elements by Hedy
Version Model Number	HE-PFS
Catalog Number	HE-PFS
Company DUNS	249482399
Company Name	Hedy Canada
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	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	D903HEPFS1 [Primary]

Steralize Prior To Use	false
Device Is Sterile	false

D903HEVPSMR1	Dental Impression Material - Elements VPS Medium Body Reg-Set Kit
D903HEVPSMNR1	Dental Impression Material - Elements VPS MONO. Body Reg-Set Kit
D903HEVPSMNF1	Dental Impression Material - Elements VPS MONO. Body Fast-Set Kit
D903HEVPSMF1	Dental Impression Material - Elements VPS Medium Body Fast-Set Kit
D903HEVPSLR1	Dental Impression Material - Elements VPS Light Body Reg-Set Kit
D903HEVPSLF1	Dental Impression Material - Elements VPS Light Body Fast-Set Kit
D903HEVPSHR1	Dental Impression Material - Elements VPS Heavy Body Reg-Set Kit
D903HEVPSHF1	Dental Impression Material - Elements VPS Heavy Body Fast-Set Kit
D903HEPRS1	Dental Impression Material - Elements VPS Putty Regular-Set
D903HEPFS1	Dental Impression Material - Elements VPS Putty Fast-Set
D903HEBRSFS1	Dental Impression Material - Elements Bite Registration SuperFast-Set
D903HEBRRS1	Dental Impression Material - Elements Bite Registration Reg-Set Kit
D903HEBRFS1	Dental Impression Material - Elements Bite Registration Fast-Set Kit