PD-IT-S

GUDID 14560264562049

NAKANISHI INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 14560264562049
• NIH Device Record Key: 5f66cf18-b516-4b9b-889f-3e9eb82717a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PD-IT-S
• Version Model Number: PD-IT-S
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 10
• 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: true
• Lot Batch: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool and dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560264562042 [Unit of Use]
GS1	14560264562049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132264

FDA Product Code

• HBC: MOTOR, DRILL, ELECTRIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-16

Devices Manufactured by NAKANISHI INC.

• 04560264575158 - Nozzle Holder: 2024-11-25
• 04560264575165 - Nozzle Holder: 2024-11-25
• 04560264575172 - Internal Spray Nozzle: 2024-11-25
• 04560264575189 - Cleaning Wire: 2024-11-25
• 04560264575271 - Tube Holder: 2024-11-25
• 04560264576506 - Protection Plug: 2024-11-25
• 04560264576513 - Coolant Solution Hanger Post: 2024-11-25
• 04589551392421 - Tube Holder: 2024-11-25