Duns Number:042823948
Device Description: Cook, Silicone Balloon HSG Catheter With Closed End And Sideport
Catalog Number
J-CHSG-703001
Brand Name
Cook
Version/Model Number
G17471
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"
-
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
-
Product Code
LKF
Product Code Name
Cannula, manipulator/injector, uterine
Public Device Record Key
f1b71403-4279-4360-883a-7c15920104c7
Public Version Date
September 21, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10827002174716
Quantity per Package
10
Contains DI Package
00827002174719
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 | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |