Insufflation Tubing, Gen Use 15/22mm

GUDID 10817183020346

Insufflation Tubing for use with Laparoscopic Insufflators with a 15 or 22mm connection

NORTHGATE TECHNOLOGIES INC.

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 10817183020346
• NIH Device Record Key: 0a288a8e-83ec-46c4-b76a-545241684ec0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insufflation Tubing, Gen Use 15/22mm
• Version Model Number: 7-510-46
• 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	00817183020349 [Primary]
GS1	10817183020346 [Package]; Contains: 00817183020349; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914403

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-14

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