Duns Number:657528899
Device Description: HSG catheters may be used to evaluate the causes of abnormal uterine bleeding, menstrual d HSG catheters may be used to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurrent pregnancy loss or unexplained infertility. These devices are also very useful for the assessment of uterine pathology and assessment of patients on tamoxifen therapy.
Catalog Number
-
Brand Name
NA
Version/Model Number
BA05F-S
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
K092983,K092983
Product Code
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
b51f9099-f376-4337-98f3-fff51d56ff38
Public Version Date
June 25, 2020
Public Version Number
2
DI Record Publish Date
July 09, 2018
Package DI Number
04713025224011
Quantity per Package
10
Contains DI Package
04713025224004
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 |