P300-1T-H

GUDID 04589551354504

NAKANISHI INC.

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 04589551354504
• NIH Device Record Key: 3b6660fb-955d-4248-b2aa-7b2293b9c49d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P300-1T-H
• Version Model Number: P300-1T-H
• 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: true
• Serial Number: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04589551354443 [Primary]
GS1	04589551354504 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202120

FDA Product Code

• HWE: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

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

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

[04589551354504]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-18
• Device Publish Date: 2022-05-10

Devices Manufactured by NAKANISHI INC.

• 04589551383993 - Bur Stopper: 2024-11-21
• 04589551384006 - Bur Stopper Puller: 2024-11-21
• 04560264502963 - PTL Nozzle: 2024-11-11
• 04560264502970 - EZ-M4 Adaptor: 2024-11-11
• 04589551392063 - EZ SPRAY: 2024-11-11
• 04589551391950 - M205: 2024-10-24
• 04560264578586 - FX204 M4: 2024-10-24
• 04589551389391 - Surgic Pro2 OPT: 2024-10-23