Kitazato ET Catheter Type1-v6 EC-PRO Normal 205023

GUDID 04580303269510

4.7Fr 230mm EC-PRO Inner Catheter

KITAZATO CORPORATION

Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set

• Primary Device ID: 04580303269510
• NIH Device Record Key: 26d36823-bc52-4952-9374-e5c3f7ef87cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitazato ET Catheter Type1-v6 EC-PRO Normal
• Version Model Number: 205023 Type1-v6 EC-PRO Normal
• Catalog Number: 205023
• 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	04580303269510 [Primary]
GS1	14580303269517 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-29
• Device Publish Date: 2018-06-19

On-Brand Devices [Kitazato ET Catheter Type1-v6 EC-PRO Normal]

• 04580303269510: 4.7Fr 230mm EC-PRO Inner Catheter
• 14580303309510: 4.7Fr 230mm EC-PRO Inner Catheter