Duns Number:801895244
Device Description: H/S Procedure Tray • 7 French • Integrated Stylet for Hysterosonography and Hysterosalping H/S Procedure Tray • 7 French • Integrated Stylet for Hysterosonography and Hysterosalpingography
Catalog Number
-
Brand Name
H/S Procedure Tray • 7 French • Integrated Stylet
Version/Model Number
61-3207
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
K020954,K020954
Product Code
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
f1796ba0-0cf7-4834-87e7-eeb695ae4e5d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 04, 2017
Package DI Number
20888937016431
Quantity per Package
10
Contains DI Package
60888937016439
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 |