Kitazato ET Catheter Type1-v3 EC-PRO Normal 275018

GUDID 14580303269487

4.7Fr 180mm Trial EC-PRO Cathter and Outer Guide

KITAZATO CORPORATION

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• Primary Device ID: 14580303269487
• NIH Device Record Key: d95574b0-4144-40f5-8455-21eaba9e3b9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitazato ET Catheter Type1-v3 EC-PRO Normal
• Version Model Number: 275018 Type1-v3 EC-PRO Normal
• Catalog Number: 275018
• Company DUNS: 711091157
• Company Name: KITAZATO CORPORATION
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04580303269480 [Primary]
GS1	14580303269487 [Package]; Contains: 04580303269480; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162878

FDA Product Code

• MQF: CATHETER, ASSISTED REPRODUCTION

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: 2019-02-07

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