rainbow High Shine AT9822A2

GUDID 08809324760124

Dental Ceramic

GENOSS CO., Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 08809324760124
• NIH Device Record Key: 9839d638-225e-4d00-a32c-839a59580a57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rainbow High Shine
• Version Model Number: AT9822A2
• Catalog Number: AT9822A2
• Company DUNS: 690083006
• Company Name: GENOSS CO., Ltd.
• Device Count: 1
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 22 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809324760124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151842

FDA Product Code

• EIH: POWDER, PORCELAIN

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: 2019-10-01
• Device Publish Date: 2019-09-23

On-Brand Devices [rainbow High Shine]

• 08809324760124: Dental Ceramic
• 08809324760117: Dental Ceramic