rainbow shine SH9812A0

GUDID 08809552960037

Dental ceramic

GENOSS CO., Ltd.

Skin staple remover, reusable

• Primary Device ID: 08809552960037
• NIH Device Record Key: e67be7e0-407e-420f-85a8-e60145242fdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rainbow shine
• Version Model Number: SH9812A0
• Catalog Number: SH9812A0
• 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: true
• 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

• Outer Diameter: 98 Millimeter
• Outer Diameter: 98 Millimeter
• Outer Diameter: 98 Millimeter
• Outer Diameter: 98 Millimeter
• Outer Diameter: 98 Millimeter
• Outer Diameter: 98 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809552960037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160079

FDA Product Code

• EIH: POWDER, PORCELAIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2017-12-20

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