Select Sil Heavy Viscosity SEL-SIL-SHRS-GR50

GUDID 17540208000247

Super hydrophilic correction impression material based on addition curing vinyl silicones - Heavy body, regular set

Zendo Direct AG

Silicone dental impression material

• Primary Device ID: 17540208000247
• NIH Device Record Key: e319eb59-0eb0-4b54-951c-49efdbf6de3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Select Sil Heavy Viscosity
• Version Model Number: SEL-SIL-SHRS-GR50
• Catalog Number: SEL-SIL-SHRS-GR50
• Company DUNS: 486717338
• Company Name: Zendo Direct AG
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage temperature: max. 77°F (25°C)

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540208000240 [Primary]
GS1	17540208000247 [Package]; Contains: 07540208000240; 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: 2017-02-21

On-Brand Devices [Select Sil Heavy Viscosity]

• 17540208000452: Super hydrophilic correction impression material based on addition curing vinyl silicones - Heav
• 17540208000247: Super hydrophilic correction impression material based on addition curing vinyl silicones - Heav