Tube Holder

GUDID 04589551392421

NAKANISHI INC.

Surgical power tool system control unit, line-powered

• Primary Device ID: 04589551392421
• NIH Device Record Key: 9903f76b-767b-4a8c-be66-ce842a757a45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tube Holder
• Version Model Number: Tube Holder
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 7
• 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: false
• Lot Batch: false
• Serial Number: false
• 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	04560264576605 [Primary]
GS1	04589551392421 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233117

FDA Product Code

• EBW: Controller, foot, handpiece and cord

Sterilization

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

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

[04589551392421]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-25
• Device Publish Date: 2024-11-15

On-Brand Devices [Tube Holder]

• 04589551392421: Tube Holder
• 04560264575271: Tube Holder