TCR Mono 756205

GUDID E1997562051

Dental appliance fabrication material, resin

Primary Device ID	E1997562051
NIH Device Record Key	acd6a65e-ce90-4d29-9e79-c0e3fa759f8b
Commercial Distribution Status	In Commercial Distribution
Brand Name	TCR Mono
Version Model Number	756205
Catalog Number	756205
Company DUNS	480467422
Company Name	Candulor AG
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
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	07630813462233 [Primary]
HIBCC	E1997562051 [Primary]

ELM	Denture, plastic, teeth

Steralize Prior To Use	false
Device Is Sterile	false