Select Flow SEL-LCFLOWA1

GUDID 17540208000254

Light cure easy flowable microhybrid composite - Needle Tubes; Shade A1

Zendo Direct AG

Dental composite resin Dental composite resin

• Primary Device ID: 17540208000254
• NIH Device Record Key: d8a6df5f-b188-4ff8-b195-fd6a00ca0672
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Select Flow
• Version Model Number: SEL-LCFLOWA1
• Catalog Number: SEL-LCFLOWA1
• Company DUNS: 486717338
• Company Name: Zendo Direct AG
• Device Count: 20
• 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: true
• 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)
• Special Storage Condition, Specify: Between 0 and 0 *Storage temperature: max. 77°F (25°C)

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540208000257 [Unit of Use]
GS1	17540208000254 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2017-03-07

On-Brand Devices [Select Flow ]

• 17540208000278: Light cure easy flowable microhybrid composite - Needle Tubes; Shade A3
• 17540208000261: Light cure easy flowable microhybrid composite - Needle Tubes; Shade A2
• 17540208000254: Light cure easy flowable microhybrid composite - Needle Tubes; Shade A1