Polysil Heavy Viscosity Regular Set SH-103

GUDID 17540196000526

Dental impression material to reproduce the structure of a patient's teeth and gums. Packaged in a cartridge system. Heavy viscosity, regular set.

Scican Ltd

Silicone dental impression material
Primary Device ID17540196000526
NIH Device Record Keye8b2b00f-207e-472b-8c0c-d716f440a685
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolysil Heavy Viscosity Regular Set
Version Model NumberSH-103
Catalog NumberSH-103
Company DUNS204137145
Company NameScican Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18006677733
Emailtboyce@scican.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature (65°-73°F / 18°-23°C).

Device Identifiers

Device Issuing AgencyDevice ID
GS107540196000529 [Primary]
GS117540196000526 [Package]
Contains: 07540196000529
Package: Carton [2 Units]
In Commercial Distribution

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-02

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