VisCalor bulk

GUDID E22160631

set contains Caps Sticks A1, A2, A3, uni, Caps Warmer

VOCO GmbH

Dental composite resin

• Primary Device ID: E22160631
• NIH Device Record Key: b0211856-f85c-48e3-a00c-346204125615
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisCalor bulk
• Version Model Number: 6063
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 80
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E2216063 [Unit of Use]
HIBCC	E22160631 [Primary]

FDA Product Code

• EFC: Warmer, Anesthetic Tube

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: 2019-05-20
• Device Publish Date: 2019-05-10

On-Brand Devices [VisCalor bulk]

• E22160681: 6068
• E22160671: 6067
• E22160661: 6066
• E22160651: 6065
• E22160631: set contains Caps Sticks A1, A2, A3, uni, Caps Warmer
• E22160621: set contains Caps Sticks A1, A2, A3, uni, VisCalor Dispenser