S-Max pico SL

GUDID 04560264525078

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: 04560264525078
• NIH Device Record Key: 7f91b3b7-4a3b-4778-b37c-b501ded8eb7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-Max pico SL
• Version Model Number: S-Max pico SL
• 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	04560264525078 [Direct Marking]
GS1	04560264574595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203791

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

[04560264525078]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-01
• Device Publish Date: 2022-10-24

On-Brand Devices [S-Max pico SL]

• 04560264573444: S-Max pico SL
• 04560264525078: S-Max pico SL