Duns Number:657528899
Device Description: HSG catheter sets can be used for sonohysterography and hysterosalpingography procedures t HSG catheter sets can be used for sonohysterography and hysterosalpingography procedures that greatly enhance the analysis of uterine pathology. Using HSG balloon catheters, the procedures are simple and non-traumatic for your patients. A placement sheath eliminates the need for a tenaculum. HSG catheters are designed for single patient use only.
Catalog Number
-
Brand Name
NA
Version/Model Number
BA071F
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
Yes
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
3b913111-8610-4dd7-b577-13f76fa06fef
Public Version Date
June 25, 2020
Public Version Number
4
DI Record Publish Date
August 15, 2016
Package DI Number
04715309121931
Quantity per Package
10
Contains DI Package
04715309125120
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 |