Duns Number:657528899
Device Description: The catheter is to be used for sonohysterography procedure that aid in the analysis of ute The catheter is to be used for sonohysterography procedure that aid in the analysis of uterine pathology. A placement sheath eliminates the need for a tenaculum. This catheter is designed for single patient use.
Catalog Number
-
Brand Name
NA
Version/Model Number
UIC5F
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
K102898,K102898
Product Code
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
e634d787-cc15-4be0-a7d8-da09d7b7ddef
Public Version Date
June 25, 2020
Public Version Number
4
DI Record Publish Date
August 15, 2016
Package DI Number
04715309121900
Quantity per Package
25
Contains DI Package
04715309125069
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 676 |
| U | Unclassified | 1 |