Suction Tubing Set

GUDID 10817183020629

Suction Tubing Set with Filter

NORTHGATE TECHNOLOGIES INC.

Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube

• Primary Device ID: 10817183020629
• NIH Device Record Key: 4be1f76a-12a5-4b45-ac11-8b4a7ed65cda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suction Tubing Set
• Version Model Number: 72-00327-0
• Company DUNS: 627969264
• Company Name: NORTHGATE TECHNOLOGIES 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817183020622 [Primary]
GS1	10817183020629 [Package]; Contains: 00817183020622; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953162

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-27
• Device Publish Date: 2019-06-19

On-Brand Devices [Suction Tubing Set]

• 10817183020629: Suction Tubing Set with Filter
• 10817183020414: 7-510-44