MI Varnish™ 004274

GUDID 00386040004636

MI Varnish™ Fresh Strawberry, 50 unit doses , 0.55g (0.5 mL), 50 disposable green applicators

Gc America Inc.

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• Primary Device ID: 00386040004636
• NIH Device Record Key: 396e61b1-2cf4-4742-9a11-2146a88f16b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MI Varnish™
• Version Model Number: 004274
• Catalog Number: 004274
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 50
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386040004636 [Unit of Use]
GS1	10386040004633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102808

FDA Product Code

• LBH: VARNISH, CAVITY

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: 2022-07-13
• Device Publish Date: 2022-07-05

On-Brand Devices [MI Varnish™]

• 00386040004650: MI Varnish™ Fresh Mint, 50 unit doses, 0.55g (0.5 mL), 50
• 00386040004636: MI Varnish™ Fresh Strawberry, 50 unit doses , 0.55g (0.5 mL), 50 disposable green applicators