MEDICOM DURAFLOR ULTRA 1016-C30

GUDID 20686864040976

DURAFLOR ULTRA VARNISH 5% FLUORIDE CARAMEL -DOSE

AMD Medicom Inc

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• Primary Device ID: 20686864040976
• NIH Device Record Key: 5776c368-1069-4a37-9db2-59cddea43507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDICOM DURAFLOR ULTRA
• Version Model Number: 1016-C30
• Catalog Number: 1016-C30
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 30
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.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
• 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 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864040972 [Unit of Use]
GS1	10686864040979 [Primary]
GS1	20686864040976 [Package]; Contains: 10686864040979; Package: PACK [6 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: 5
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-09-15

On-Brand Devices [MEDICOM DURAFLOR ULTRA]

• 20686864041027: DURAFLOR ULTRA VARNISH 5% FLUORIDE SAMPLE PACK -DOSE
• 20686864041010: DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE
• 20686864041003: DURAFLOR ULTRA VARNISH 5% FLUORIDE CARAMEL -DOSE
• 20686864040990: DURAFLOR ULTRA VARNISH 5% FLUORIDE MINT -DOSE
• 20686864040983: DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE
• 20686864040976: DURAFLOR ULTRA VARNISH 5% FLUORIDE CARAMEL -DOSE
• 20686864040969: DURAFLOR ULTRA VARNISH 5% FLUORIDE MINT -DOSE
• 10686864056536: DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE
• 20686864056526: DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE
• 10686864056512: DURAFLOR ULTRA VARNISH 5% FLUORIDE CHERRY - DOSE
• 10686864056505: DURAFLOR ULTRA VARNISH 5% FLUORIDE CHERRY - DOSE
• 20686864056717: DURAFLOR ULTRA VARNISH 5% FLUORIDE Sample Pack - 1 unit dose each (Bubble Gum & Cherry)
• 20686864055901: DURAFLOR ULTRA VARNISH 5% FLUORIDE ASSORTED FLAVORS - 400 units (MINT - 00686864040996 - 200 un