Duns Number:801895244
Device Description: HUMI® Harris-Kronner Uterine Manipulator-Injector O.D.: 5 mm • Length: 33 cm (13") • Recom HUMI® Harris-Kronner Uterine Manipulator-Injector O.D.: 5 mm • Length: 33 cm (13") • Recommended Balloon Inflation: Air 10 cc
Catalog Number
-
Brand Name
HUMI
Version/Model Number
6001
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
K770727,K770727
Product Code
KNA
Product Code Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Public Device Record Key
d05eadf7-ef43-442f-81ed-49cb6d345b4c
Public Version Date
December 07, 2018
Public Version Number
4
DI Record Publish Date
September 14, 2016
Package DI Number
20888937013232
Quantity per Package
12
Contains DI Package
00888937013238
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 |