Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
8881225119
Brand Name
Monoject
Version/Model Number
8881225119
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 01, 2024
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
K912563,K912563
Product Code
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
b2154d1a-e3c7-45c3-ab37-26d7cadfada7
Public Version Date
October 10, 2022
Public Version Number
9
DI Record Publish Date
September 24, 2016
Package DI Number
20884521013916
Quantity per Package
50
Contains DI Package
10884521013919
Package Discontinue Date
August 01, 2024
Package Status
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 |