Duns Number:711091157
Catalog Number
328000
Brand Name
Kitazato OPU Needle
Version/Model Number
328000
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
MQE
Product Code Name
NEEDLE, ASSISTED REPRODUCTION
Public Device Record Key
f217fd54-a8db-47e0-bcc7-1b1fd0e14c39
Public Version Date
October 05, 2022
Public Version Number
1
DI Record Publish Date
September 27, 2022
Package DI Number
14580745041801
Quantity per Package
10
Contains DI Package
04580745041804
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 |