Duns Number:130814890
Device Description: Balloon catheter with an insertion sheathfor hysterosalpingography and sonohysterographyfo Balloon catheter with an insertion sheathfor hysterosalpingography and sonohysterographyfor use with saline or water-based contrast media
Catalog Number
TMI1183
Brand Name
NA
Version/Model Number
Two-Tap Shapeable HS Catheter, 5F
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
7e791a78-b90b-4b1e-9275-e8110f75c091
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 30, 2016
Package DI Number
10852073002835
Quantity per Package
10
Contains DI Package
00852073002838
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |