Duns Number:243880700
Device Description: H/S Catheters are latex free medical devices used to inject contrast media or saline into H/S Catheters are latex free medical devices used to inject contrast media or saline into the uterus through the fluid lumen of the tube. This devices consist of a flexible (size 5FR) tube with a balloon at the distal end. Intended to be used during sonohysterography and Hysterosalpingography procedures.
Catalog Number
51-5005
Brand Name
Batrik H/S Catheter TM 5F
Version/Model Number
51-5005
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
K032835,K032835
Product Code
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
60ba6aa4-d6c0-406e-8756-c9d061c7b584
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
June 05, 2018
Package DI Number
00690521009318
Quantity per Package
10
Contains DI Package
00690521013735
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 | 748 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |