PANA SPRAY Plus

GUDID 04589551393367

NAKANISHI INC.

Surgical instrument maintenance lubricant

• Primary Device ID: 04589551393367
• NIH Device Record Key: 864f898e-fd38-463e-a00c-a5f43d3bdb49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANA SPRAY Plus
• Version Model Number: PANA SPRAY Plus
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• 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	04589551393367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163483

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-02
• Device Publish Date: 2025-09-24

On-Brand Devices [PANA SPRAY Plus]

• 04560264538566: PANA SPRAY Plus
• 04589551393367: PANA SPRAY Plus