Duns Number:711091157
Catalog Number
101073
Brand Name
Kitazato IUI Catheter without Stainless Steel Center Core Type1-v2
Version/Model Number
101073 Type2-v2
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
1d7416d1-65d8-41e7-97bd-bcf96675e3fc
Public Version Date
March 29, 2021
Public Version Number
5
DI Record Publish Date
November 09, 2016
Package DI Number
14580303269036
Quantity per Package
10
Contains DI Package
04580303269039
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 |