Duns Number:801895244
Device Description: ZUI 4.0™ Uterine Injector O.D.: 4.0 mm • Length: 23 cm (9")
Catalog Number
-
Brand Name
ZUI
Version/Model Number
ZSI1152
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"
Yes
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
K941458,K941458
Product Code
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
376cc3f1-4b1d-46ff-b096-089777ded6ce
Public Version Date
December 07, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
20888937013638
Quantity per Package
12
Contains DI Package
00888937013634
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |