Kitazato ET Catheter Type1-v1 EC-PRO Normal 215018

GUDID 14580303269463

4.7Fr 180mm EC-PRO inner Catheter and Outer Guide

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 ID14580303269463
NIH Device Record Key3ca78aa7-eb88-404a-b90e-09c6f095dea3
Commercial Distribution StatusIn Commercial Distribution
Brand NameKitazato ET Catheter Type1-v1 EC-PRO Normal
Version Model Number215018 Type1-v1 EC-PRO Normal
Catalog Number215018
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
GS104580303269466 [Primary]
GS114580303269463 [Package]
Contains: 04580303269466
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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-09
Device Publish Date2018-06-19

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