PD-CTTU-600504

GUDID 04589551362943

NAKANISHI INC.

Luminal device flushing tubing set, reusable

• Primary Device ID: 04589551362943
• NIH Device Record Key: 62cb8046-63e9-4da1-835f-a90b58aef88d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PD-CTTU-600504
• Version Model Number: PD-CTTU-600504
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 4
• 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: 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	04589551354573 [Primary]
GS1	04589551362943 [Unit of Use]

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: false
• Device Is Sterile: false

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.

• 04589551365197 - Primado2: 2025-02-17
• 04589551365234 - NSK Sterile Burs/Drills: 2025-02-17
• 04589551365241 - NSK Sterile Burs/Drills: 2025-02-17
• 04589551365258 - NSK Sterile Burs/Drills: 2025-02-17
• 04589551365265 - NSK Sterile Burs/Drills: 2025-02-17
• 04589551391127 - Perio-Mate: 2025-02-12
• 04589551391134 - Perio-Mate: 2025-02-12
• 04589551391141 - Perio-Mate: 2025-02-12