Duns Number:801895244
Device Description: Uterine manipulator, box of 12
Catalog Number
-
Brand Name
Kronner Manipujector
Version/Model Number
6003
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
K904473,K904473
Product Code
HES
Product Code Name
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Public Device Record Key
894bd4ac-5171-4b7c-9813-bab6e4504e6b
Public Version Date
March 04, 2019
Public Version Number
1
DI Record Publish Date
January 31, 2019
Package DI Number
20888937014765
Quantity per Package
12
Contains DI Package
00888937015805
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 | 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 |