Citrine 56-00200

GUDID 10353045002346

Citrine 5% Sodium Fluoride Varnish, Spearmint Flavor - 50 x 0.4ml Unit-doses, 50 Applicator Brushes, 1 Doctor Instruction Insert and 50 Patient Instruction Inserts

DHARMA RESEARCH, INC.

Dental coating, tooth-desensitizing

• Primary Device ID: 10353045002346
• NIH Device Record Key: 5c77e7f8-97e5-4ad6-af6c-25f5b7e2c9a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Citrine
• Version Model Number: 56-00200
• Catalog Number: 56-00200
• Company DUNS: 078444642
• Company Name: DHARMA RESEARCH, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com
• Phone: 8778333725
• Email: info@dharmaresearch.com

Device Dimensions

• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353045002349 [Primary]
GS1	00353045002646 [Unit of Use]
GS1	10353045002346 [Package]; Contains: 00353045002349; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• LBH: Varnish, Cavity

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-07

On-Brand Devices [Citrine]

• 10353045002360: Citrine 5% Sodium Fluoride Varnish, Bubble Gum Flavor - 50 x 0.4ml Unit-doses, 50 Applicator Bru
• 10353045002353: Citrine 5% Sodium Fluoride Varnish, Vanilla Cake Flavor - 50 x 0.4ml Unit-doses, 50 Applicator B
• 10353045002346: Citrine 5% Sodium Fluoride Varnish, Spearmint Flavor - 50 x 0.4ml Unit-doses, 50 Applicator Brus