Kitazato ET Catheter Type2-v1 EC-PRO Supported 215118

GUDID 14580303269548

4.7Fr 180mm EC-PRO Supported Inner Catheter and Outer Guide

KITAZATO CORPORATION

Assisted reproduction transfer catheter/set
Primary Device ID14580303269548
NIH Device Record Key52613562-2d87-4249-a200-218fbb256792
Commercial Distribution StatusIn Commercial Distribution
Brand NameKitazato ET Catheter Type2-v1 EC-PRO Supported
Version Model Number215118 Type2-v1 EC-PRO Supported
Catalog Number215118
Company DUNS711091157
Company NameKITAZATO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104580303269541 [Primary]
GS114580303269548 [Package]
Contains: 04580303269541
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQFCATHETER, ASSISTED REPRODUCTION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-07

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