Visalys Flow 15035

GUDID E217150351

Visalys Flow Opaque A2, 1 x 1,8 g Syringe (US)

Kettenbach GmbH & Co. KG

Dental composite resin

• Primary Device ID: E217150351
• NIH Device Record Key: 9c5a23d3-f7c0-4134-b6eb-5f17738f462e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visalys Flow
• Version Model Number: 15035
• Catalog Number: 15035
• 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	E217150351 [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)