Select Sil Medium Body SEL-SIL-MB-SHRS-PNK5

GUDID 17540208000223

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

Zendo Direct AG

Silicone dental impression material

• Primary Device ID: 17540208000223
• NIH Device Record Key: 71310c40-8299-4fa2-a238-aca87ccbe5e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Select Sil Medium Body
• Version Model Number: SEL-SIL-MB-SHRS-PNK5
• Catalog Number: SEL-SIL-MB-SHRS-PNK5
• 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	07540208000226 [Primary]
GS1	17540208000223 [Package]; Contains: 07540208000226; 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: 2017-07-04

On-Brand Devices [Select Sil Medium Body]

• 17540208000469: Super hydrophilic correction impression material based on addition curing vinyl silicones - Medi
• 17540208000223: Super hydrophilic correction impression material based on addition curing vinyl silicones - Medi