rainbow Block W9822

GUDID 08809324768434

Dental Ceramic

GENOSS CO., Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 08809324768434
• NIH Device Record Key: 1bcbcfb2-460d-4b3a-83b8-83573144b266
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rainbow Block
• Version Model Number: W9822
• Catalog Number: W9822
• 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	08809324768434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092513

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 Block]

• 08809324768441: Dental Ceramic
• 08809324768434: Dental Ceramic
• 08809324768427: Dental Ceramic
• 08809324768410: Dental Ceramic
• 08809324768403: Dental Ceramic
• 08809324768397: Dental Ceramic
• 08809324768380: Dental Ceramic