Visalys Flow 15032

GUDID E217150321

Visalys Flow A3, 1 x 1,8 g Syringe (US)

Kettenbach GmbH & Co. KG

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: E217150321
• NIH Device Record Key: 75c318b7-3b72-45d1-a165-6329006c2e96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visalys Flow
• Version Model Number: 15032
• Catalog Number: 15032
• Company DUNS: 316803246
• Company Name: Kettenbach GmbH & Co. KG
• 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: 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

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E217150321 [Primary]

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-02
• Device Publish Date: 2023-02-22

On-Brand Devices [Visalys Flow]

• E217150361: Visalys Flow Bleach, 1 x 1,8 g Syringe (US)
• E217150351: Visalys Flow Opaque A2, 1 x 1,8 g Syringe (US)
• E217150341: Visalys Flow A4, 1 x 1,8 g Syringe (US)
• E217150331: Visalys Flow A3.5, 1 x 1,8 g Syringe (US)
• E217150321: Visalys Flow A3, 1 x 1,8 g Syringe (US)
• E217150311: Visalys Flow A2, 1 x 1,8 g Syringe (US)
• E217150301: Visalys Flow A1, 1 x 1,8 g Syringe (US)