Image

GUDID 00814978023387

Regular Set DustFree Alginate Dental Impression Material Mint Starter Pak

Kerr Corporation

Alginate dental impression material

• Primary Device ID: 00814978023387
• NIH Device Record Key: 54939b5a-c4f0-4a2a-9193-cf32a72d3529
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Image
• Version Model Number: 27426DX
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• Device Count: 1
• 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: false
• 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
• 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
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814978023387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160097

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: 2016-09-12

On-Brand Devices [Image]

• 00814978023387: Regular Set DustFree Alginate Dental Impression Material Mint Starter Pak
• 00814978023370: Fast Set DustFree Alginate Dental Impression Material Mint Starter Pak
• 00814978021413: DustFree Alginate Dental Impression Material Mint Sample Set Time: 3 Minutes
• 10814978023810: Regular Set DustFree Alginate Dental Impression Material Mint Value Pak
• 10814978023803: Regular Set DustFree Alginate Dental Impression Material Mint Institutional Pak
• 10814978023797: Fast Set DustFree Alginate Dental Impression Material Mint Value Pak
• 10814978023780: Fast Set DustFree Alginate Dental Impression Material Mint Institutional Pak
• 10814978023766: Regular Set (3 Minutes) DustFree Alginate Dental Impression Material Mint Refill Pack
• 10814978023728: Fast Set (2 Minutes) DustFree Alginate Dental Impression Material Mint Refill Pack