RIVA COAT 8610001

GUDID DO3686100011

Dental pit/fissure sealant

Primary Device ID	DO3686100011
NIH Device Record Key	fd8d9a45-04a3-4cf8-9df8-ec27ea9308f8
Commercial Distribution Status	In Commercial Distribution
Brand Name	RIVA COAT
Version Model Number	RIVA COAT 5ML PK
Catalog Number	8610001
Company DUNS	753221852
Company Name	SDI LIMITED
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

Phone	+18002285166
Email	info@sdi.com.au

Handling Environment Atmospheric Pressure

Between 10 Degrees Celsius and 25 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	DO3686100011 [Primary]

EBC	SEALANT, PIT AND FISSURE, AND CONDITIONER

Steralize Prior To Use	false
Device Is Sterile	false