Duns Number:080935429
Device Description: 3 mL Syringe with Standard Hypodermic Needle
Catalog Number
8881513033
Brand Name
Monoject
Version/Model Number
8881513033
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
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
514bd76e-6b5c-44ea-8cf8-2e244e6a5cb1
Public Version Date
June 17, 2019
Public Version Number
7
DI Record Publish Date
October 14, 2016
Package DI Number
10884521012653
Quantity per Package
1000
Contains DI Package
20884521012650
Package Discontinue Date
-
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 |