Duns Number:809524291
Device Description: Koala® Intrauterine Pressure Catheter with internal balloon
Catalog Number
-
Brand Name
Koala®
Version/Model Number
IPC-5000C
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
K974389,K974389,K974389
Product Code
HFN
Product Code Name
Transducer, Pressure, Intrauterine
Public Device Record Key
d89b02ce-47bf-49c5-a8d5-7533e3e25fd0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
10814247020151
Quantity per Package
10
Contains DI Package
00814247020154
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |