Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
84064
Brand Name
Kangaroo
Version/Model Number
84064
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
-
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
KYZ
Product Code Name
SYRINGE, IRRIGATING (NON DENTAL)
Public Device Record Key
e46c6e26-341d-4d6e-b682-56cd8e630f49
Public Version Date
February 15, 2019
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20884521002064
Quantity per Package
30
Contains DI Package
10884521002067
Package Discontinue Date
April 05, 2000
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |