Kitazato ET Catheter Type2-v2 EC-PRO Supported 215123

GUDID 14580303269555

4.7Fr 230mm EC-PRO Supported Inner Catheter and Outer Guide

KITAZATO CORPORATION

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• Primary Device ID: 14580303269555
• NIH Device Record Key: e3d95150-5e21-4545-bca5-99ce6f00eb5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitazato ET Catheter Type2-v2 EC-PRO Supported
• Version Model Number: 215123 Type2-v2 EC-PRO Supported
• Catalog Number: 215123
• 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	04580303269558 [Primary]
GS1	14580303269555 [Package]; Contains: 04580303269558; 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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