TheraCem Ca D-46502S

GUDID 00810111541329

Dental composite resin

Primary Device ID	00810111541329
NIH Device Record Key	1d48a5a3-6a8e-47fa-89bb-fe09ca6367f3
Commercial Distribution Status	In Commercial Distribution
Brand Name	TheraCem Ca
Version Model Number	D-46502S
Catalog Number	D-46502S
Company DUNS	053529939
Company Name	BISCO INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
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

Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 25 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00810111541329 [Primary]
HIBCC	D757D46502S0 [Previous]

EMA	Cement, Dental

Steralize Prior To Use	false
Device Is Sterile	false

D757D46502S0	THERACEM Ca 1G DUAL SYR SAMPLE
D757D46502PS0	THERACEM Ca 1g DUAL SYR SMPL PKG
D757D465010	THERACEM Ca 8g DUAL SYRINGE
00810111541312	THERACEM Ca 8g REFILL PACKAGE
00810111541336	THERACEM Ca 1g DUAL SYR SMPL PKG
00810111541305	THERACEM Ca 8g DUAL SYRINGE
00810111541329	THERACEM Ca 1G DUAL SYR SAMPLE