FX57

GUDID 04560264578494

NAKANISHI INC.

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• Primary Device ID: 04560264578494
• NIH Device Record Key: bd5d20b5-3464-4a72-bf44-1627bd0c08e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX57
• Version Model Number: FX57
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04560264578326 [Primary]
GS1	04560264578494 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222518

FDA Product Code

• EGS: Handpiece, contra- and right-angle attachment, dental

Sterilization

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

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-20
• Device Publish Date: 2023-03-10

Devices Manufactured by NAKANISHI INC.

• 04560264500730 - Primado2: 2024-04-03
• 04560264500747 - Primado2: 2024-04-03
• 04560264511668 - Primado2: 2024-04-03
• 04560264511675 - Primado2: 2024-04-03
• 04560264511705 - Primado2: 2024-04-03
• 04560264511736 - Primado2: 2024-04-03
• 04560264523081 - Primado2: 2024-04-03
• 04560264523098 - Primado2: 2024-04-03