KromaFaze Singles

GUDID 00841396116650

Dust Free Color Changing Alginate Dental Impression Material Fast Set

Kerr Corporation

Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material

• Primary Device ID: 00841396116650
• NIH Device Record Key: bf18092a-42cc-455d-948b-e784ba9a4449
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KromaFaze Singles
• Version Model Number: 27444DX
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• Device Count: 125
• 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

Customer Support Contacts

• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com
• Phone: +18005377123
• Email: customercare@kavokerrgroup.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396116650 [Primary]
GS1	10841396116657 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160441

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-31

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• 00195062048845 - Buchanan Hand Pluggers: 2024-01-19 Buchanan Hand Plugger, Size #2
• 00195062048852 - Buchanan Hand Pluggers: 2024-01-19 Buchanan Hand Plugger, Size #0