Duns Number:080935429
Device Description: 6 mL Syringe with Standard Hypodermic Needle
Catalog Number
8881516135
Brand Name
Monoject
Version/Model Number
8881516135
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2023
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
-
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
defc8cfd-80d4-4929-b1bc-a352f9b6c2f8
Public Version Date
October 27, 2022
Public Version Number
6
DI Record Publish Date
October 13, 2016
Package DI Number
10884521014152
Quantity per Package
500
Contains DI Package
20884521014159
Package Discontinue Date
January 01, 2023
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 |