Duns Number:711091157
Device Description: 4.7Fr 230mm Trial EC-PRO Cathter and Outer Guide
Catalog Number
275023
Brand Name
Kitazato ET Catheter Type1-v4 EC-PRO Normal
Version/Model Number
275023 Type1-v4 EC-PRO Normal
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQF
Product Code Name
CATHETER, ASSISTED REPRODUCTION
Public Device Record Key
22f62ab2-281d-4860-9733-cc5fa1e13e22
Public Version Date
March 29, 2021
Public Version Number
2
DI Record Publish Date
February 07, 2019
Package DI Number
14580303269494
Quantity per Package
10
Contains DI Package
04580303269497
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 177 |