P300-2A80

GUDID 04589551355228

NAKANISHI INC.

Burring power tool attachment

• Primary Device ID: 04589551355228
• NIH Device Record Key: 4b33e8cf-651c-4f76-a5f1-439e2a5a1860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P300-2A80
• Version Model Number: P300-2A80
• 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	04589551355167 [Primary]
GS1	04589551355228 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202120

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

[04589551355228]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-21
• Device Publish Date: 2022-09-15

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