Suction Tubing Set

GUDID 10817183020414

NORTHGATE TECHNOLOGIES INC.

Surgical plume evacuation system tube

• Primary Device ID: 10817183020414
• NIH Device Record Key: 1c5ab974-3a2f-483c-91f6-bd57c25e671b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suction Tubing Set
• Version Model Number: 7-510-44
• 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	00817183020417 [Primary]
GS1	10817183020414 [Package]; Contains: 00817183020417; 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: 2019-03-11
• Device Publish Date: 2019-02-22

On-Brand Devices [Suction Tubing Set]

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