Polysil Heavy Viscosity Fast Set SH-103/F

GUDID 17540196000533

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

Scican Ltd

Silicone dental impression material

• Primary Device ID: 17540196000533
• NIH Device Record Key: e7b2993c-097e-4fc8-bf05-1ac21e8e75f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polysil Heavy Viscosity Fast Set
• Version Model Number: SH-103/F
• Catalog Number: SH-103/F
• Company DUNS: 204137145
• Company Name: Scican Ltd
• 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: 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

Customer Support Contacts

• Phone: 18006677733
• Email: tboyce@scican.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540196000536 [Primary]
GS1	17540196000533 [Package]; Contains: 07540196000536; Package: Carton [2 Units]; In Commercial Distribution

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-02

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