Duns Number:130814890
Device Description: Balloon catheter with an insertion sheathfor hysterosalpingography and saline infusion son Balloon catheter with an insertion sheathfor hysterosalpingography and saline infusion sonohysterography
Catalog Number
TMI2001
Brand Name
MIller Advance Catheter
Version/Model Number
5F HS Catheter
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
K123258,K123258
Product Code
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
72142c3a-75f8-4caf-a8ec-a48c83c10dec
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 11, 2016
Package DI Number
10852073002217
Quantity per Package
10
Contains DI Package
00852073002210
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 |