Duns Number:801895244
Device Description: GyneCath Catheter • 7F for Hysterosonography and Hysterosalpingography
Catalog Number
-
Brand Name
GyneCath Catheter • 7F
Version/Model Number
19611
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
K961752,K961752,K961752
Product Code
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
02dc3c2d-967c-40a5-a58c-120656cc6cd3
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 22, 2018
Package DI Number
30888937016568
Quantity per Package
4
Contains DI Package
20888937016561
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |