rainbow shine SH9810A2

GUDID 08809552960020

Dental ceramic

GENOSS CO., Ltd.

Skin staple remover, reusable Skin staple remover, reusable Skin staple remover, reusable Skin staple remover, reusable Skin staple remover, reusable Skin staple remover, reusable

• Primary Device ID: 08809552960020
• NIH Device Record Key: ca75fb02-c00c-43b9-9d33-e28fb4543374
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rainbow shine
• Version Model Number: SH9810A2
• Catalog Number: SH9810A2
• 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	08809552960020 [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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